- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02487771
Kansas University DHA Outcome Study (KUDOS) Follow-Up
2018년 1월 29일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
190
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Kansas
-
Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
16년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약 캡슐
|
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
|
실험적: DHA Capsule
|
600 mg DHA capsule
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adaptive Regulation Assessment
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anthropometrics: Weight-for-age
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Susan E Carlson, PhD, University of Kansas Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 7월 1일
기본 완료 (실제)
2016년 5월 1일
연구 완료 (실제)
2016년 5월 1일
연구 등록 날짜
최초 제출
2012년 6월 18일
QC 기준을 충족하는 최초 제출
2015년 6월 30일
처음 게시됨 (추정)
2015년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 2월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 29일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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