Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutrition and Cognition in Indian Children (CHAMPION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467909
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 1, 2007
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
St. John's Research Institute

Tracking Information
First Submitted Date  ICMJE April 30, 2007
First Posted Date  ICMJE May 1, 2007
Last Update Posted Date May 1, 2007
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
Cognitive development and performance [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
Growth, Morbidity, Immune function and gut function [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition and Cognition in Indian Children
Official Title  ICMJE Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: micronutrients
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2007)
600
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467909
Other Study ID Numbers  ICMJE 04B9-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE St. John's Research Institute
Collaborators  ICMJE Unilever R&D
Investigators  ICMJE
Principal Investigator: Anura V Kurpad, MD St. John's Research Institute
PRS Account St. John's Research Institute
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP