Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Cognitive development and performance
研究概览
简要总结
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. A randomised, double-blind, placebo-controlled 2x2 factorial design will be conducted to assess the effect of a micronutrient with or without omega-3 fatty acids on cognitive development and performance and other selected outcome variables such as growth, morbidity and immune response in children of 7-9 years of age in India.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
The drink (nutritional item) was prepared daily, for each child individually, by mixing 65 g of the powder in 160 mL boiled water. The fortified products in the 4 treatment groups were each assigned a specific color code, which was displayed on the package, but were otherwise indistinguishable in color, appearance, and taste. The investigators, assessors of cognitive tests, and participants were blinded until the study was completed, all data were entered, and the initial analyses were performed.
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7to 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 less than 1 year.
排除标准
- •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.
结局指标
主要结局
Cognitive development and performance
时间窗: 1 year
Cognitive performance was measured at baseline and at 6 and 12 mo.
次要结局
- Growth, Morbidity, Immune function and gut function(1 year)