Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Kansas University DHA Outcome Study (KUDOS) Follow-Up

29 januari 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

190

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 35 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo-capsule
Geneesmiddel: Placebo Capsule
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
Experimenteel: DHA Capsule
Geneesmiddel: DHA
600 mg DHA capsule
Andere namen:
  • docosahexaeenzuur

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adaptive Regulation Assessment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anthropometrics: Weight-for-age
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Susan Carlson, PhD

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Hoofdonderzoeker: Susan E Carlson, PhD, University of Kansas Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2008

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 mei 2016

Studieregistratiedata

Eerst ingediend

18 juni 2012

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2015

Eerst geplaatst (Schatting)

1 juli 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 februari 2018

Laatste update ingediend die voldeed aan QC-criteria

29 januari 2018

Laatst geverifieerd

1 januari 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 11406
  • 1R01HD047315 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Placebo Capsule

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in India

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren