- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00467909
Nutrition and Cognition in Indian Children (CHAMPION)
Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
연구 개요
상세 설명
Nutritional deficiencies are a major problem in school children in India and have a variety of adverse effects on their cognitive development and growth, and increase susceptibility to infections. There is strong evidence for beneficial effects of iodine, iron and protein-energy on cognitive development in children, while evidence for vitamin B6, vitamin B12, folate, zinc and, omega-3 fatty acids and in particular docosahexanoic acid (DHA) is limited and inconclusive. The present study will investigate the efficacy of foods fortified with omega-3 fatty acids including DHA and a micronutrient mix (iodine, iron, vitamin B2, vitamin B6, vitamin B12, folate, zinc, calcium, vitamin A, vitamin C and vitamin E) on improving cognitive development and performance in school children in India.
The study will follow a randomised, double-blind, placebo-controlled 2x2 factorial design in which children aged 7-9 years will be randomised to one of four treatment groups and prospectively followed for a period of twelve months to assess cognitive development and performance and other selected outcome variables such as growth, morbidity and immune response. Intervention will take place in primary schools, where children will receive three intervention products daily. The products will contain omega-3 fatty acids with micronutrients, or micronutrients only, or omega3 fatty acids only or a placebo. At baseline, 6 and 12 months cognitive tests will be administered and blood samples will be drawn to assess nutritional status and immune response to hepatitis B vaccination. Compliance will be measured daily and morbidity will be monitored weekly by means of a questionnaire. Anthropometric measurements will be carried out monthly.
It is expected that, after 12 months of intervention, children consuming products containing omega-3 fatty acids with micronutrients will have statistically significant higher scores and higher improvement in scores on cognitive tests, will grow taller and have a better immune response than children consuming control products.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Karnataka
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Bangalore, Karnataka, 인도, 560034
- St John's Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged 7-9 years, not having their tenth birthday close to the start of the study
- Children attending the primary schools in Bangalore area in India which are selected in the cross-sectional survey
- Healthy as assessed by a physician
- Willing to consume the test product
- Willing to participate in the study and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry, dietary intake and questionnaires.
- Informed consent signed by parent or caregiver and oral consent given by child
- Parents intend to stay in the study area for 1 year.
Exclusion Criteria:
- Children with obvious mental and physical handicaps
- Children using medication which interferes with study measurements
- Reported dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the study
- Severely undernourished as defined by HAZ, WAZ or WHZ greater than -3 SD from NCHS reference standard z-scores (Ogden et al, 2002)
- Severely iron deficient as defined by hemoglobin concentrations <80 g/L (WHO, 2001)
- Reported participation in another biomedical trial 3 months before the start of the study or during the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Cognitive development and performance
기간: 1 year
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1 year
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2차 결과 측정
결과 측정 |
기간 |
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Growth, Morbidity, Immune function and gut function
기간: 1 year
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1 year
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Anura V Kurpad, MD, St. John's Research Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .