Status:
COMPLETED
Nutrition and Cognition in Indian Children
Lead Sponsor:
St. John's Research Institute
Collaborating Sponsors:
Unilever R&D
Conditions:
Healthy
Eligibility:
All Genders
7-9 years
Phase:
NA
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. 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. The...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00467909
Start Date
November 1 2005
End Date
March 31 2007
Last Update
May 22 2024
Active Locations (1)
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1
St John's research Institute
Bangalore, Karnataka, India, 560034