Nutrition, Physical Performance & Fitness in Indian School Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00876018
First received: April 3, 2009
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Physical Fitness
Nutritional Status
Other: Nutritional supplement
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Double Blind Randomized Controlled Trial in School Going Children, to Evaluate the Impact of a Multiple Micronutrient Fortified Nutritional Powder on Physical Performance Measures

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Physical fitness and performance [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nutritional status [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Muscle strength and endurance [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
No intervention
Experimental: Nutritional supplement
Fortified nutritional powder
Other: Nutritional supplement
Fortified nutritional powder
Placebo Comparator: Placebo
Un-fortified nutritional powder
Other: Placebo
Un-fortified nutritional powder

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 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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876018

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00876018     History of Changes
Other Study ID Numbers: IND 001/2008
Study First Received: April 3, 2009
Last Updated: July 25, 2012
Health Authority: India: IERB

Keywords provided by GlaxoSmithKline:
physical performance
micronutrients
physical fitness
healthy children

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014