Nutrition, Physical Performance & Fitness in Indian School Children

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 4

Conditions

Nutritional Status
Physical Fitness

Treatments

Other: Nutritional supplement
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00876018
IND 001/2008

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

7 to 11 years old

Volunteers

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

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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