Nutrition and Cognition in Indian Children

NCT00467909 | Completed

• 1 other identifier: 04B9-P
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

micronutrients; cognition; DHA; healthy children

Outcome Measures

Primary Outcomes (1)

• Cognitive development and performance

  Cognitive performance was measured at baseline and at 6 and 12 mo.

  1 year

Secondary Outcomes (1)

• Growth, Morbidity, Immune function and gut function

  1 year

Study Arms (4)

Hgh micronutrients, high n-3 fatty acid treatment Arm

EXPERIMENTAL

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

low micronutrients, high n-3 fatty acid treatment

EXPERIMENTAL

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micronutrients per kcal proportional to that consumed by the children in their habitual diet (S Muthayya, 2006, unpublished observations).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

low micronutrients, low n-3 fatty acid treatment.

EXPERIMENTAL

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

high micronutrients, low n-3 fatty acid treatment

EXPERIMENTAL

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

Interventions

micronutrients BEHAVIORAL

Hgh micronutrients, high n-3 fatty acid treatment Arm; high micronutrients, low n-3 fatty acid treatment; low micronutrients, high n-3 fatty acid treatment; low micronutrients, low n-3 fatty acid treatment.

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. John's Research Institute: lead
• Unilever R&D: collaborator

Study Sites (1)

St John's research Institute

Bangalore, Karnataka, 560034, India

Location

Related Publications (1)

• Muthayya S, Eilander A, Transler C, Thomas T, van der Knaap HC, Srinivasan K, van Klinken BJ, Osendarp SJ, Kurpad AV. Effect of fortification with multiple micronutrients and n-3 fatty acids on growth and cognitive performance in Indian schoolchildren: the CHAMPION (Children's Health and Mental Performance Influenced by Optimal Nutrition) Study. Am J Clin Nutr. 2009 Jun;89(6):1766-75. doi: 10.3945/ajcn.2008.26993. Epub 2009 Apr 15.

  PMID: 19369376 RESULT

MeSH Terms

Interventions

Micronutrients

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anura V Kurpad, MD

  St. John's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a 2-by-2 factorial, double-blind, randomized controlled trial, 598 children aged 6-10 y were individually allocated to 1 of 4 intervention groups to receive foods fortified with either 100% or 15% of the Recommended Dietary Allowance of micronutrients in combination with either 900 mg α-linolenic acid plus 100 mg docosahexaenoic acid or 140 mg α-linolenic acid for 12 mo. Anthropometric and biochemical assessments were performed at baseline and 12 mo. Cognitive performance was measured at baseline and at 6 and 12 mo.

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 1, 2007
• Study Start: November 1, 2005
• Primary Completion: March 31, 2007
• Study Completion: March 31, 2007
• Last Updated: May 22, 2024

Record last verified: 2007-04

Locations

IN (1)