- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876018
Nutrition, Physical Performance & Fitness in Indian School Children
February 28, 2018 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karnataka
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Bangalore, Karnataka, India, 560034
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Experimental: Nutritional supplement
Fortified nutritional powder
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Fortified nutritional powder
|
Placebo Comparator: Placebo
Un-fortified nutritional powder
|
Un-fortified nutritional powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
Time Frame: Baseline, after 4 months
|
Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise.
VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants.
In this test, participants were asked to step at 22 steps a minute for 3 minutes.
The pulse rate was recorded manually, within 15sec of stopping the test.
VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years.
HRmax= maximum heart rate.
VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min.
mL/kg/min.=
milliliter per kilogram per minute.
|
Baseline, after 4 months
|
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
Time Frame: Baseline, after 4 months
|
Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test.
VO2peak was measured by 20m shuttle run test to assess aerobic & whole body endurance.
In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction & in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals.
The initial pace was set at 4.0 km/hr & with subsequent increases of 0.5 km/hr every subsequent minute.
This test was conducted in groups (of at least 3 children per group).
The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was > 1m away from cone at 2 consecutive paced signals.
The number of shuttles at stoppage was noted.
VO2peak was calculated as 31.025
+ (3.325 x speed) - (3.248 x age).
Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.
|
Baseline, after 4 months
|
Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
Time Frame: Baseline, after 4 months
|
A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch.
The moment any part of the designated participant's body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.
|
Baseline, after 4 months
|
Change From Baseline in Visual Reaction Time After 4 Months
Time Frame: Baseline, after 4 months
|
Visual reaction time was assessed using a customized computer based programme.
Participant was provided with a periodic random test visual stimulus among many other 'non test' stimuli.
Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus.
Three test visual cues were provided at each sitting to allow for training effects.
The shortest visual reaction time of the three visual cues was used in analyses.
|
Baseline, after 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Time Frame: Baseline, after 4 months
|
Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms.
The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment.
Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements.
|
Baseline, after 4 months
|
Change From Baseline in Time to Fatigue After 4 Months
Time Frame: Baseline, after 4 months
|
Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value.
Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength.
In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value.
|
Baseline, after 4 months
|
Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
Time Frame: Baseline, after 4 months
|
Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm.
Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm.
The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value.
Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue).
|
Baseline, after 4 months
|
Change From Baseline in Hemoglobin Level After 4 Months
Time Frame: Baseline, after 4 months
|
Hemoglobin level was measured to assess the iron status in study participants.
|
Baseline, after 4 months
|
Change From Baseline in Ferritin Level After 4 Months
Time Frame: Baseline, after 4 months
|
Ferritin level was measured to assess the iron status of study participants.
|
Baseline, after 4 months
|
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
Time Frame: Baseline, after 4 months
|
Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.
|
Baseline, after 4 months
|
Change From Baseline in C-reactive Protein Level After 4 Months
Time Frame: Baseline, after 4 months
|
C-reactive protein level was measured.
|
Baseline, after 4 months
|
Change From Baseline in Vitamin B2 Level After 4 Months
Time Frame: Baseline, after 4 months
|
Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.
|
Baseline, after 4 months
|
Change From Baseline in Vitamin B6 Level After 4 Months
Time Frame: Baseline, after 4 months
|
Vitamin B6 level was measured as micronutrient markers in study participants.
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Baseline, after 4 months
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Change From Baseline in Vitamin B12 Level After 4 Months
Time Frame: Baseline, after 4 months
|
Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.
|
Baseline, after 4 months
|
Change From Baseline in Folate Level After 4 Months
Time Frame: Baseline, after 4 months
|
Folate level was measured as micronutrient markers in study participants.
|
Baseline, after 4 months
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Change From Baseline in Vitamin C Level After 4 Months
Time Frame: Baseline, after 4 months
|
Vitamin C level was measured as micronutrient markers in study participants.
|
Baseline, after 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2008
Primary Completion (Actual)
December 19, 2008
Study Completion (Actual)
December 19, 2008
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 3, 2009
First Posted (Estimate)
April 6, 2009
Study Record Updates
Last Update Posted (Actual)
March 1, 2018
Last Update Submitted That Met QC Criteria
February 28, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IND 001/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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