Phase 4
Completed N=300
Nutrition, Physical Performance & Fitness in Indian School Children
Physical Fitness · Nutritional Status
Source: ClinicalTrials.gov NCT00876018 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: 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
◆ Published Evidence
Established
37citations · ~3 / year
Aerobic fitness, micronutrient status, and academic achievement in Indian school-aged children.
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.
Linked Publications (2)
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Aerobic fitness, micronutrient status, and academic achievement in Indian school-aged children.
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Micronutrient supplementation improves physical performance measures in Asian Indian school-age children.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00876018) and the linked publication. 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. Informational only — not medical advice.