Clinical trial NCT00876018: Nutrition, Physical Performance & Fitness in Indian School Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Physical Fitness
Nutritional Status
Keywords: physical performance
micronutrients
physical fitness
healthy children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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 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.

Primary outcomes:
measure: Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Visual Reaction Time After 4 Months
timeFrame: Baseline, after 4 months
Secondary outcomes:
measure: Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Time to Fatigue After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Hemoglobin Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Ferritin Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in C-reactive Protein Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Vitamin B2 Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Vitamin B6 Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Vitamin B12 Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Folate Level After 4 Months
timeFrame: Baseline, after 4 months
measure: Change From Baseline in Vitamin C Level After 4 Months
timeFrame: Baseline, after 4 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
state: Karnataka
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Desai IK, Kurpad AV, Chomitz VR, Thomas T. Aerobic fitness, micronutrient status, and academic achievement in Indian school-aged children. PLoS One. 2015 Mar 25;10(3):e0122487. doi: 10.1371/journal.pone.0122487. eCollection 2015.
citation: Vaz M, Pauline M, Unni US, Parikh P, Thomas T, Bharathi AV, Avadhany S, Muthayya S, Mehra R, Kurpad AV. Micronutrient supplementation improves physical performance measures in Asian Indian school-age children. J Nutr. 2011 Nov;141(11):2017-23. doi: 10.3945/jn.110.135012. Epub 2011 Sep 14.