Nutrition and Cognition in Indian Children (CHAMPION)

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT00467909
First received: April 30, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Behavioral: micronutrients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Official Title: Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India

Resource links provided by NLM:


Further study details as provided by St. John's Research Institute:

Primary Outcome Measures:
  • Cognitive development and performance [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Growth, Morbidity, Immune function and gut function [ Time Frame: 1 year ]

Enrollment: 600
Study Start Date: November 2005
Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children aged 7-9 years, not having their tenth birthday close to the start of the study
  2. Children attending the primary schools in Bangalore area in India which are selected in the cross-sectional survey
  3. Healthy as assessed by a physician
  4. Willing to consume the test product
  5. Willing to participate in the study and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry, dietary intake and questionnaires.
  6. Informed consent signed by parent or caregiver and oral consent given by child
  7. Parents intend to stay in the study area for 1 year.

Exclusion Criteria:

  1. Children with obvious mental and physical handicaps
  2. Children using medication which interferes with study measurements
  3. Reported dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the study
  4. Severely undernourished as defined by HAZ, WAZ or WHZ greater than –3 SD from NCHS reference standard z-scores (Ogden et al, 2002)
  5. Severely iron deficient as defined by hemoglobin concentrations <80 g/L (WHO, 2001)
  6. Reported participation in another biomedical trial 3 months before the start of the study or during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467909

Locations
India
St John's research Institute
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
St. John's Research Institute
Unilever R&D
Investigators
Principal Investigator: Anura V Kurpad, MD St. John's Research Institute
  More Information

No publications provided by St. John's Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00467909     History of Changes
Other Study ID Numbers: 04B9-P
Study First Received: April 30, 2007
Last Updated: April 30, 2007
Health Authority: India: Institutional Review Board

Keywords provided by St. John's Research Institute:
micronutrients
cognition
DHA
healthy children

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014