Nutrition and Cognition in Indian Children (CHAMPION)
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|ClinicalTrials.gov Identifier: NCT00467909|
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 1, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Behavioral: micronutrients||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India|
|Study Start Date :||November 2005|
|Actual Study Completion Date :||February 2007|
- Cognitive development and performance [ Time Frame: 1 year ]
- Growth, Morbidity, Immune function and gut function [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467909
|St John's research Institute|
|Bangalore, Karnataka, India, 560034|
|Principal Investigator:||Anura V Kurpad, MD||St. John's Research Institute|