Status:
COMPLETED
Nutrition, Physical Performance & Fitness in Indian School Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Physical Fitness
Nutritional Status
Eligibility:
All Genders
7-11 years
Phase:
PHASE4
Brief 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.
Detailed 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 a...
Eligibility Criteria
Inclusion
- Boys and girls between ages 7-10.5 years
- Z score of height for age and weight for age of 0 to \< -3
- Good general health at screening
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Written informed consent from the parents/ guardians and writtent assent by the study participant
Exclusion
- Severe anemia (Hb\<8 g% )
- Cardiovascular disease on clinical examination or history
- Any underlying respiratory disease with impairment of lung function
- Physical disability Children consuming nutritional supplements (tonics, syrups, tablets or chews) and/ or health food drinks on a regular basis
- Recent history \[3mo\] of serious infections, injuries and/ or surgeries
- Participation in any nutritional study in the last 1 year
- Indication that they are likely to move within the period of study intervention
- Any known food allergies like peanut allergy, gluten allergy
- Family members of an employee of the Sponsor or the study site.
Key Trial Info
Start Date :
July 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00876018
Start Date
July 7 2008
End Date
December 19 2008
Last Update
March 1 2018
Active Locations (1)
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1
GSK Investigational Site
Bangalore, Karnataka, India, 560034