Kansas University DHA Outcome Study (KUDOS) Follow-Up
29 de janeiro de 2018 atualizado por: Susan Carlson, PhD
This is a continuation study to KUDOS (NCT00266825).
The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Numerous trials show benefits of postnatal DHA supplementation for visual acuity.
There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function.
Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development.
The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years.
Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations.
Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
Tipo de estudo
Intervencional
Inscrição (Real)
190
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Kansas
-
Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
16 anos a 35 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
- Agree to consume study capsules from enrollment until delivery
- Agree to return to the study center for delivery
- BMI < 40
- No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
- Available by telephone
Exclusion Criteria:
- Less than 16 or greater than 35 years of age
- BMI < 40
- Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
- Expecting multiple infants
- Diabetes or gestational diabetes at baseline
- Elevated blood pressure due to any cause
- Not planning to return to the study center for delivery
- Gestational age at baseline < 8 weeks or >20 weeks
- Unable or unwilling to agree to consume capsules until delivery
- Unable to provide informed consent in English
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo Cápsula
|
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
|
Experimental: DHA Capsule
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600 mg DHA capsule
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Prazo: 36 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
36 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Prazo: 48 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
48 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Prazo: 72 Months
|
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains.
At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance).
For the older ages the score can range from 40 to 160.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
72 Months
|
|
Cognitive Function Score - Peabody Picture Vocabulary Test
Prazo: 60 Months
|
The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary.
The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
|
60 Months
|
|
Cognitive Function Score - Test of Preschool Early Literacy
Prazo: 42 Months
|
The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition.
The score is based on assessments of vocabulary, print knowledge, and phonological awareness.
The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
|
42 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Prazo: 36 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
36 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Prazo: 48 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
48 Months
|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
Prazo: 72 Months
|
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning.
At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance).
For the older ages the score can range from 46 to 155.
For all ages the assessment is normed to a Mean = 100, St Dev = 15.
|
72 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adaptive Regulation Assessment
Prazo: 36 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
36 Months
|
|
Adaptive Regulation Assessment
Prazo: 48 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
48 Months
|
|
Adaptive Regulation Assessment
Prazo: 60 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
60 Months
|
|
Adaptive Regulation Assessment
Prazo: 72 Months
|
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent.
Externalizing Problems is a measure of Aggression and Hyperactivity.
Internalizing Problems is a measure of Anxiety, Depression, and Somatization.
The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems.
Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership.
All scores are derived from the general, combined sex normative tables of T-Scores.
For Adaptive Skills higher T-Scores reflect a more optimal outcome.
For all other measures lower T-Scores reflect a more optimal outcome.
All T-Scores were standardized with a Mean = 50, St Dev = 10.
|
72 Months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anthropometrics: Weight-for-age
Prazo: 2 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
2 years
|
|
Anthropometrics: Weight-for-age
Prazo: 2.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
2.5 years
|
|
Anthropometrics: Weight-for-age
Prazo: 3 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
3 years
|
|
Anthropometrics: Height-for-Age
Prazo: 2 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
2 years
|
|
Anthropometrics: Weight-for-age
Prazo: 3.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
3.5 years
|
|
Anthropometrics: Weight-for-age
Prazo: 4 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
4 years
|
|
Anthropometrics: Weight-for-age
Prazo: 4.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
4.5 years
|
|
Anthropometrics: Weight-for-age
Prazo: 5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
5 years
|
|
Anthropometrics: Weight-for-age
Prazo: 5.5 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
5.5 years
|
|
Anthropometrics: Weight-for-age
Prazo: 6 years
|
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
|
6 years
|
|
Anthropometrics: Height-for-Age
Prazo: 2.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
2.5 years
|
|
Anthropometrics: Height-for-Age
Prazo: 3 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
3 years
|
|
Anthropometrics: Height-for-Age
Prazo: 3.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
3.5 years
|
|
Anthropometrics: Height-for-Age
Prazo: 4 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
4 years
|
|
Anthropometrics: Height-for-Age
Prazo: 4.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
4.5 years
|
|
Anthropometrics: Height-for-Age
Prazo: 5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
5 years
|
|
Anthropometrics: Height-for-Age
Prazo: 5.5 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
5.5 years
|
|
Anthropometrics: Height-for-Age
Prazo: 6 years
|
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA).
Braids, ponytails or other hair artifacts were removed or subtracted when needed.
|
6 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 2 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
2 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 2.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
2.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 3 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
3 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 3.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
3.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 4 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
4 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 4.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
4.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
5 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 5.5 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
5.5 years
|
|
Anthropometrics: Body Mass Index-for-age
Prazo: 6 years
|
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
|
6 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 2 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
2 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 2.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
2.5 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 3 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
3 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 3.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
3.5 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 4 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
4 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 4.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
4.5 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
5 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 5.5 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
5.5 years
|
|
Anthropometrics: Head Circumference-for-age
Prazo: 6 years
|
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue).
Braids, ponytails, glasses or other artifacts were removed whenever possible.
|
6 years
|
|
Dietary Intake
Prazo: 2 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
2 years
|
|
Dietary Intake
Prazo: 2.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
2.5 years
|
|
Dietary Intake
Prazo: 3 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
3 years
|
|
Dietary Intake
Prazo: 3.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
3.5 years
|
|
Dietary Intake
Prazo: 4 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
4 years
|
|
Dietary Intake
Prazo: 4.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
4.5 years
|
|
Dietary Intake
Prazo: 5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
5 years
|
|
Dietary Intake
Prazo: 5.5 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
5.5 years
|
|
Dietary Intake
Prazo: 6 years
|
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach.
When necessary both the parent and child participated in the recall process to increase overall reliability.
Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian.
Reliability and caloric intake data are presented here.
Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes.
Caloric intake is the mean kcal per day from reliable recalls only.
|
6 years
|
|
Systolic Blood Pressure
Prazo: 4 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Systolic Blood Pressure
Prazo: 4.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Systolic Blood Pressure
Prazo: 5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Systolic Blood Pressure
Prazo: 5.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Systolic Blood Pressure
Prazo: 6 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
|
Diastolic Blood Pressure
Prazo: 4 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Diastolic Blood Pressure
Prazo: 4.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Diastolic Blood Pressure
Prazo: 5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Diastolic Blood Pressure
Prazo: 5.5 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Diastolic Blood Pressure
Prazo: 6 years
|
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
|
Heart Rate
Prazo: 4 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4 years
|
|
Heart Rate
Prazo: 4.5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
4.5 years
|
|
Heart Rate
Prazo: 5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5 years
|
|
Heart Rate
Prazo: 5.5 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
5.5 years
|
|
Heart Rate
Prazo: 6 years
|
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state.
Raw averages are reported here, including outliers.
Not all subjects participated in triplicate measures.
|
6 years
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan E Carlson, PhD, University of Kansas Medical Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Colombo J, Shaddy DJ, Gustafson K, Gajewski BJ, Thodosoff JM, Kerling E, Carlson SE. The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation. Am J Clin Nutr. 2019 May 1;109(5):1380-1392. doi: 10.1093/ajcn/nqz018.
- Kerling EH, Hilton JM, Thodosoff JM, Wick J, Colombo J, Carlson SE. Effect of Prenatal Docosahexaenoic Acid Supplementation on Blood Pressure in Children With Overweight Condition or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190088. doi: 10.1001/jamanetworkopen.2019.0088.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2008
Conclusão Primária (Real)
1 de maio de 2016
Conclusão do estudo (Real)
1 de maio de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
18 de junho de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de junho de 2015
Primeira postagem (Estimativa)
1 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de fevereiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de janeiro de 2018
Última verificação
1 de janeiro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 11406
- 1R01HD047315 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .