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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St John's research Institute

Bangalore, Karnataka, India, 560034