Nutrition, Physical Performance & Fitness in Indian School Children

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Phase 4


Nutritional Status
Physical Fitness


Other: Nutritional supplement
Other: Placebo

Study type


Funder types



IND 001/2008

Details and patient eligibility


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.

Full 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.


300 patients




7 to 11 years old


Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


Double Blind

300 participants in 3 patient groups, including a placebo group

No intervention
No Intervention group
No intervention
Nutritional supplement
Experimental group
Fortified nutritional powder
Other: Nutritional supplement
Placebo Comparator group
Un-fortified nutritional powder
Other: Placebo

Trial contacts and locations



Data sourced from

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