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Clinical Trial Summary

The purpose of this study is to evaluate the effect of nutritional supplement on physical performance measures of apparently healthy school going children in India.


Clinical Trial Description

Nutritional status may be important in achieving optimal physical performance. There is evidence of significant improvements in physical fitness, aerobic capacity and anaerobic threshold of children and adolescents with nutritional intervention, albeit in children with initial sub-optimal nutritional status. This may be of particular relevance in developing countries like India, where there is limited data on physical fitness and a wide-spread prevalence of concurrent micronutrient deficiencies even in apparently normal school age children. The present study therefore, is designed to assess the effect of a nutritional supplement on the physical performance measures of school going children. This is a randomized, double blind placebo-controlled study of three treatment groups (1 test, 1 positive control (placebo) and 1 'no intervention') conducted in equal numbers of male or female children [ages 7-11] attending day schools in Bangalore. Subjects in the intervention (test and positive control) groups will receive study treatments (fortified or un-fortified nutritional powder) once a day for 4 months. The treatments will be administered under supervision on all school working days; for the weekend and other holidays, sachets will be provided for home consumption. At baseline and 4months, physical performance tests will be administered and blood sample drawn to assess nutritional status. Other selected outcome measures such as nutrition status and muscle strength/ endurance will also be assessed. It is hypothesized that after 4 months of intervention, children consuming fortified nutritional powder will have statistically significant improvements in physical performance/ fitness measures as compared to the two control groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00876018
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 4
Start date July 7, 2008
Completion date December 19, 2008

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