Physical FitnessPhase 4NCT00876018
Nutrition, Physical Performance & Fitness in Indian School Children
A Phase 4 study testing Nutritional supplement in people with Physical Fitness and Nutritional Status, run by GlaxoSmithKline at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Nutritional Status
- What is being tested?
- Nutritional supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jul 2008to 19 Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Physical Fitness, Nutritional Status
- Being tested
- Nutritional supplement, Placebo
- Keywords
- physical performance, micronutrients, physical fitness, healthy children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementOther
Fortified nutritional powder
PlaceboOther
Un-fortified nutritional powder
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No intervention |
| Nutritional supplement | Experimental | Fortified nutritional powder Receives: Other: Nutritional supplement |
| Placebo | Placebo comparator | Un-fortified nutritional powder Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test 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.
Measured: Baseline, after 4 months
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) 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.
Measured: Baseline, after 4 months
Change From Baseline in Time Taken for 40 Meter (m) Sprint 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.
Measured: Baseline, after 4 months
Change From Baseline in Visual Reaction Time 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.
Measured: Baseline, after 4 months
Secondary outcomes (12)
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand 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.
Measured: Baseline, after 4 months
Change From Baseline in Time to Fatigue 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.
Measured: Baseline, after 4 months
Change From Baseline in Rate of Decline of Muscle Strength 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).
Measured: Baseline, after 4 months
Change From Baseline in Hemoglobin Level After 4 Months
Hemoglobin level was measured to assess the iron status in study participants.
Measured: Baseline, after 4 months
Change From Baseline in Ferritin Level After 4 Months
Ferritin level was measured to assess the iron status of study participants.
Measured: Baseline, after 4 months
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.
Measured: Baseline, after 4 months
Change From Baseline in C-reactive Protein Level After 4 Months
C-reactive protein level was measured.
Measured: Baseline, after 4 months
Change From Baseline in Vitamin B2 Level After 4 Months
Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.
Measured: Baseline, after 4 months
Change From Baseline in Vitamin B6 Level After 4 Months
Vitamin B6 level was measured as micronutrient markers in study participants.
Measured: Baseline, after 4 months
Change From Baseline in Vitamin B12 Level After 4 Months
Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.
Measured: Baseline, after 4 months
Change From Baseline in Folate Level After 4 Months
Folate level was measured as micronutrient markers in study participants.
Measured: Baseline, after 4 months
Change From Baseline in Vitamin C Level After 4 Months
Vitamin C level was measured as micronutrient markers in study participants.
Measured: Baseline, after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study start7 Jul 2008
- Primary completion19 Dec 2008
- Study completion19 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876018
- Sponsor's protocol ID
- IND 001/2008
- Status last verified
- Feb 2018
- First submitted
- 3 Apr 2009
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 25806824Vaz 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.
PubMed 21918063
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00876018
- Acronym / sponsor ID
- IND 001/2008
- Conditions
- Physical Fitness, Nutritional Status
- Keywords
- physical performance, micronutrients, physical fitness, healthy children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2008 (actual)
- Primary completion
- 19 Dec 2008 (actual)
- Study completion
- 19 Dec 2008 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Posted 3 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No intervention |
| Nutritional supplement | Experimental | Other: Nutritional supplementFortified nutritional powder |
| Placebo | Placebo comparator | Other: PlaceboUn-fortified nutritional powder |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementFortified nutritional powder | Other | Nutritional supplement |
| PlaceboUn-fortified nutritional powder | Other | Placebo |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Time to Fatigue After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Hemoglobin Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Ferritin Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in C-reactive Protein Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Vitamin B2 Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Vitamin B6 Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Vitamin B12 Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Folate Level After 4 Months
Time frame: Baseline, after 4 months
Change From Baseline in Vitamin C Level After 4 Months
Time frame: Baseline, after 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25806824Desai 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.
- Derived from this study: PubMed 21918063Vaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutritional supplement in people with Physical Fitness and Nutritional Status, run by GlaxoSmithKline at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months (time frame: Baseline, after 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876018, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.