Phase 4 N=300 Randomized Double-blind Other

Nutrition, Physical Performance & Fitness in Indian School Children

Physical Fitness · Nutritional Status

Bottom Line

View on ClinicalTrials.gov: NCT00876018 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months — 36.8; 37.9; 37.0; 38.9 mL/kg/min. — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nutritional supplement (Other); Placebo (Other)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months	36.8; 37.9; 37.0; 38.9; 37.6; 37.8	0.004 sig
PRIMARY Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months	31.6; 32.8; 32.4; 39.1; 38.6; 38.2	0.002 sig
PRIMARY Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months	9.0; 8.9; 8.9; 8.6; 8.9; 8.639	0.153
PRIMARY Change From Baseline in Visual Reaction Time After 4 Months	958; 932; 939; 863; 884; 864	0.143
SECONDARY Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months	9.7; 9.4; 9.8; 11.1; 10.6; 10.9	—
SECONDARY Change From Baseline in Time to Fatigue After 4 Months	12.31; 12.36; 11.13; 14.71; 14.62; 14.03	—
SECONDARY Change From Baseline in Rate of Decline of Muscle Strength After 4 Months	0.38; 0.38; 0.42; 0.36; 0.33; 0.35	—
SECONDARY Change From Baseline in Hemoglobin Level After 4 Months	12.9; 12.94; 12.88; 12.7; 12.60; 12.60	—
SECONDARY Change From Baseline in Ferritin Level After 4 Months	27.59; 20.17; 24.48; 38.78; 23.89; 25.79	—
SECONDARY Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months	5.91; 6.20; 5.98; 5.75; 5.99; 6.01	—
SECONDARY Change From Baseline in C-reactive Protein Level After 4 Months	0.20; 0.30; 0.40; 0.40; 0.20; 0.40	—
SECONDARY Change From Baseline in Vitamin B2 Level After 4 Months	1.56; 1.52; 1.57; 1.22; 1.47; 1.56	—
SECONDARY Change From Baseline in Vitamin B6 Level After 4 Months	33.77; 34.28; 39.27; 59.66; 37.79; 39.77	—
SECONDARY Change From Baseline in Vitamin B12 Level After 4 Months	210.03; 213.02; 224.02; 427.82; 218.30; 220.44	—
SECONDARY Change From Baseline in Folate Level After 4 Months	583.68; 585.29; 592.82; 1013.40; 592.41; 592.93	—
SECONDARY Change From Baseline in Vitamin C Level After 4 Months	0.69; 0.61; 0.72; 1.49; 0.77; 0.76	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00876018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.