Last updated: 11/04/2018 08:21:53

Nutrition, Physical Performance & Fitness in Indian School Children

GSK study ID
IND 001/2008
Clinicaltrials.gov ID
NCT00876018
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline in maximal aerobic capacity (VO2max)- 12 inch step test after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in aerobic capacity-shuttle test (VO2peak) after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in time taken for 40 meter (m) sprint after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in visual reaction time after 4 months

Timeframe: Baseline, after 4 months

Secondary outcomes:

Change from baseline in maximal handgrip strength for dominant and non-dominant hand after 4 Months

Timeframe: Baseline, after 4 months

Change from baseline in time to fatigue after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in rate of decline of muscle strength after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in hemoglobin level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in Ferritin level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in soluble transferring receptors (sTr) after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in C-reactive protein level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in Vitamin B2 level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in Vitamin B6 level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in Vitamin B12 level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in folate level after 4 months

Timeframe: Baseline, after 4 months

Change from baseline in Vitamin C level after 4 months

Timeframe: Baseline, after 4 months

Interventions:
  • Other: Nutritional supplement
  • Other: Placebo
    • Enrollment:
    300
    Primary completion date:
    2008-19-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Physical fitness, Nutritional status
    Product
    Compound N/A
    Collaborators
    Not applicable
    Study date(s)
    July 2008 to December 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    7 - 11 years
    Accepts healthy volunteers
    Yes
    • Boys and girls between ages 7-10.5 years
    • Z score of height for age and weight for age of 0 to < -3
    • Severe anemia (Hb<8 g% )
    • Cardiovascular disease on clinical examination or history
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangalore, Karnataka, India, 560034
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-19-12
    Actual study completion date
    2008-19-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website