HealthyCHAMPIONNCT00467909
Nutrition and Cognition in Indian Children
A study testing micronutrients in people with Healthy, run by St. John's Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- micronutrients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2005to 31 Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- micronutrients
- Keywords
- micronutrients, cognition, DHA, healthy children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronutrientsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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 Receives: 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 Receives: 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.). Receives: Behavioral: micronutrients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive development and performance
Cognitive performance was measured at baseline and at 6 and 12 mo.
Measured: 1 year
Secondary outcomes (1)
Growth, Morbidity, Immune function and gut function
Weight, height (linear growth), and MUAC after 12 mo of interventionwith baseline values
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study start1 Nov 2005
- Primary completion31 Mar 2007
- Study completion31 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Anura V Kurpad, MD, Principal investigator, St. John's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467909
- Sponsor's protocol ID
- 04B9-P
- Acronym
- CHAMPION
- Status last verified
- Apr 2007
- First submitted
- 30 Apr 2007
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19369376
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
- ClinicalTrials.gov ID
- NCT00467909
- Acronym / sponsor ID
- CHAMPION / 04B9-P
- Conditions
- Healthy
- Keywords
- micronutrients, cognition, DHA, healthy children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 1 Nov 2005 (actual)
- Primary completion
- 31 Mar 2007 (actual)
- Study completion
- 31 Mar 2007 (actual)
- First posted
- 1 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hgh micronutrients, high n-3 fatty acid treatment Arm | Experimental | Behavioral: micronutrientsHigh 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.). |
| low micronutrients, high n-3 fatty acid treatment | Experimental | Behavioral: micronutrientslow 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 |
| low micronutrients, low n-3 fatty acid treatment. | Experimental | Behavioral: micronutrientslow 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 |
| high micronutrients, low n-3 fatty acid treatment | Experimental | Behavioral: micronutrientshigh 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.). |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronutrients | Behavioural | 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. |
Primary outcome
Cognitive development and performance
Time frame: 1 year
Cognitive performance was measured at baseline and at 6 and 12 mo.
1 secondary outcome
Growth, Morbidity, Immune function and gut function
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Results publication: PubMed 19369376Muthayya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anura V Kurpad, MD principal investigator
St. John's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micronutrients in people with Healthy, run by St. John's Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive development and performance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00467909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.