Nutrition and Cognition in Indian Children
Condition: Healthy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): micronutrients
Intervention type(s): Behavioral
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Keywords: micronutrients; cognition; DHA; healthy children