Nutrition and Cognition in Indian Children (CHAMPION)

May 20, 2024 updated by: St. John's Research Institute

Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • St John's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children aged 7to 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 less than 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hgh micronutrients, high n-3 fatty acid treatment Arm
High micronutrients, high n-3 fatty acid treatment The high micronutrient treatment provided 100% of the RDA of iodine, iron, riboflavin, vitamin B-6, vitamin B-12, folate, and vitamin A for children 7-9 y of age (25) (Table 1). To optimize the bioavailability of iron, zinc was provided at 92% of the RDA based on a molar ratio of 2 (iron) to 1 (zinc), vitamin C was provided at 650% of the RDA based on a molar ratio of 4 (vitamin C) to 1 (iron) and, calcium was provided at 33% of the RDA to minimize possible inhibition of iron absorption (26., 27., 28.).
Behavioral: micronutrients
Experimental: low micronutrients, high n-3 fatty acid treatment
low micronutrients, high n-3 fatty acid treatment The low micronutrient treatment delivered micronutrients per kcal proportional to that consumed by the children in their habitual diet (S Muthayya, 2006, unpublished observations). This amounted to 15% of the RDA provided in 420 kcal. The high n-3 treatment provided 900 mg ALA, which is 50% of the recommended intake of ALA for children aged 2-12 y (29), and 100 mg DHA, which corresponds with ≈50% of the recommended fish intake for children
Behavioral: micronutrients
Experimental: low micronutrients, low n-3 fatty acid treatment.
low micronutrients, low n-3 fatty acid treatment. The low micronutrient treatment delivered micronutrients per kcal proportional to that consumed by the children in their habitual diet (S Muthayya, 2006, unpublished observations). This amounted to 15% of the RDA provided in 420 kcal. The high n-3 treatment provided 900 mg ALA, which is 50% of the recommended intake of ALA for children aged 2-12 y (29), and 100 mg DHA, which corresponds with ≈50% of the recommended fish intake for children
Behavioral: micronutrients
Experimental: high micronutrients, low n-3 fatty acid treatment
high micronutrients, low n-3 fatty acid treatment The high micronutrient treatment provided 100% of the RDA of iodine, iron, riboflavin, vitamin B-6, vitamin B-12, folate, and vitamin A for children 7-9 y of age (25) (Table 1). To optimize the bioavailability of iron, zinc was provided at 92% of the RDA based on a molar ratio of 2 (iron) to 1 (zinc), vitamin C was provided at 650% of the RDA based on a molar ratio of 4 (vitamin C) to 1 (iron) and, calcium was provided at 33% of the RDA to minimize possible inhibition of iron absorption (26., 27., 28.).
Behavioral: micronutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive development and performance
Time Frame: 1 year
Cognitive performance was measured at baseline and at 6 and 12 mo.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth, Morbidity, Immune function and gut function
Time Frame: 1 year
Weight, height (linear growth), and MUAC after 12 mo of interventionwith baseline values
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

Unilever R&D

Investigators

  • Principal Investigator: Anura V Kurpad, MD, St. John's Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2005

Primary Completion (Actual)

March 31, 2007

Study Completion (Actual)

March 31, 2007

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimated)

May 1, 2007

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04B9-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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