Nutrition, Physical Performance & Fitness in Indian School Children - Full Text View

Sponsors and Collaborators:	GlaxoSmithKline St. John's Research Institute
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00876018

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
Nutritional Status Physical Fitness	Other: Placebo Other: Nutritional supplement Other: no intervention

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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

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
Estimated Study Completion Date:	May 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nutritional supplement: Experimental Fortified nutritional powder	Other: Nutritional supplement Fortified nutritional powder
Placebo: Placebo Comparator Un-fortified nutritional powder	Other: Placebo Un-fortified nutritional powder
No intervention: No Intervention no intervention	Other: no intervention no intervention

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

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

Locations

India
St. John's Research Institute
Bangalore, India

Sponsors and Collaborators

GlaxoSmithKline

St. John's Research Institute

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	IND 001/2008
Study First Received:	April 3, 2009
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00876018 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by GlaxoSmithKline:

micronutrients
physical fitness
physical performance
healthy children

Study placed in the following topic categories:

Trace Elements
Micronutrients
Healthy

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009