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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. John's Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Unilever R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04B9-P

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