Trial Outcomes & Findings for Nutrition, Physical Performance & Fitness in Indian School Children (NCT NCT00876018)
NCT ID: NCT00876018
Last Updated: 2018-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Baseline, after 4 months
Results posted on
2018-03-01
Participant Flow
Participants were recruited from three schools of Karnataka at a clinical site in Karnataka.
A total of 379 participants were screened. Out of which 300 participants were randomized.
Participant milestones
| Measure |
Experimental Group (Fortified Nutritional Supplement)
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Un-fortified Nutritional Powder)
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
95
|
95
|
97
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
Experimental Group (Fortified Nutritional Supplement)
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Un-fortified Nutritional Powder)
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrew Consent due to Adverse Event
|
5
|
4
|
2
|
Baseline Characteristics
Nutrition, Physical Performance & Fitness in Indian School Children
Baseline characteristics by cohort
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.26 Years
STANDARD_DEVIATION 1.02 • n=5 Participants
|
8.18 Years
STANDARD_DEVIATION 1.01 • n=7 Participants
|
8.29 Years
STANDARD_DEVIATION 1.04 • n=5 Participants
|
8.24 Years
STANDARD_DEVIATION 1.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
At Baseline
|
36.8 mL/kg/min.
Standard Deviation 5.3
|
37.9 mL/kg/min.
Standard Deviation 5.6
|
37.0 mL/kg/min.
Standard Deviation 5.3
|
|
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
After 4 months
|
38.9 mL/kg/min.
Standard Deviation 5.6
|
37.6 mL/kg/min.
Standard Deviation 5.3
|
37.8 mL/kg/min.
Standard Deviation 5.3
|
|
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
Change from baseline after 4 months
|
2.00 mL/kg/min.
Standard Deviation 6.03
|
-0.25 mL/kg/min.
Standard Deviation 6.23
|
0.7 mL/kg/min.
Standard Deviation 5.87
|
PRIMARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
After 4 months
|
39.1 km/hr*years
Standard Deviation 4.3
|
38.6 km/hr*years
Standard Deviation 3.7
|
38.2 km/hr*years
Standard Deviation 4.1
|
|
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
Change from baseline after 4 months
|
7.52 km/hr*years
Standard Deviation 3.51
|
5.74 km/hr*years
Standard Deviation 6.02
|
5.80 km/hr*years
Standard Deviation 3.56
|
|
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
At Baseline
|
31.6 km/hr*years
Standard Deviation 4.3
|
32.8 km/hr*years
Standard Deviation 4.1
|
32.4 km/hr*years
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
At Baseline
|
9.0 seconds (Sec)
Standard Deviation 1.3
|
8.9 seconds (Sec)
Standard Deviation 1.0
|
8.9 seconds (Sec)
Standard Deviation 1.0
|
|
Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
After 4 months
|
8.6 seconds (Sec)
Standard Deviation 1.1
|
8.9 seconds (Sec)
Standard Deviation 1.0
|
8.639 seconds (Sec)
Standard Deviation 1.0
|
|
Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
Change from baseline after 4 months
|
-0.34 seconds (Sec)
Standard Deviation 0.99
|
-0.05 seconds (Sec)
Standard Deviation 0.93
|
-0.26 seconds (Sec)
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Visual Reaction Time After 4 Months
At Baseline
|
958 milliseconds (msec)
Standard Deviation 217
|
932 milliseconds (msec)
Standard Deviation 189
|
939 milliseconds (msec)
Standard Deviation 210
|
|
Change From Baseline in Visual Reaction Time After 4 Months
After 4 months
|
863 milliseconds (msec)
Standard Deviation 144
|
884 milliseconds (msec)
Standard Deviation 122
|
864 milliseconds (msec)
Standard Deviation 157
|
|
Change From Baseline in Visual Reaction Time After 4 Months
Change from baseline after 4 months
|
-94 milliseconds (msec)
Standard Deviation 227
|
-46 milliseconds (msec)
Standard Deviation 180
|
-72 milliseconds (msec)
Standard Deviation 249
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Dominant hand, after 4 months
|
11.1 kg
Standard Deviation 3.4
|
10.6 kg
Standard Deviation 3.0
|
10.9 kg
Standard Deviation 3.2
|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Non-dominant hand, after 4 months
|
9.9 kg
Standard Deviation 3.4
|
9.47 kg
Standard Deviation 3.0
|
9.6 kg
Standard Deviation 2.6
|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Dominant hand, At Baseline
|
9.7 kg
Standard Deviation 3.9
|
9.4 kg
Standard Deviation 3.7
|
9.8 kg
Standard Deviation 3.4
|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Dominant hand, change after 4 months
|
1.41 kg
Standard Deviation 2.52
|
1.21 kg
Standard Deviation 2.91
|
1.09 kg
Standard Deviation 3.15
|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Non-dominant hand, at Baseline
|
8.6 kg
Standard Deviation 3.5
|
8.6 kg
Standard Deviation 3.5
|
8.5 kg
Standard Deviation 3.2
|
|
Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Non-dominant hand,change after 4 months
|
1.34 kg
Standard Deviation 2.55
|
0.72 kg
Standard Deviation 2.85
|
1.11 kg
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Time to Fatigue After 4 Months
After 4 months
|
14.71 sec
Standard Deviation 7.2457
|
14.62 sec
Standard Deviation 6.35
|
14.03 sec
Standard Deviation 7.25
|
|
Change From Baseline in Time to Fatigue After 4 Months
Change from baseline after 4 months
|
2.64 sec
Standard Deviation 6.37
|
2.03 sec
Standard Deviation 8.39
|
2.78 sec
Standard Deviation 6.26
|
|
Change From Baseline in Time to Fatigue After 4 Months
At Baseline
|
12.31 sec
Standard Deviation 6.71
|
12.36 sec
Standard Deviation 7.66
|
11.13 sec
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
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).
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
Change from baseline after 4 months
|
-0.01 kg/sec
Standard Deviation 0.25
|
-0.05 kg/sec
Standard Deviation 0.27
|
-0.06 kg/sec
Standard Deviation 0.28
|
|
Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
At Baseline
|
0.38 kg/sec
Standard Deviation 0.23
|
0.38 kg/sec
Standard Deviation 0.24
|
0.42 kg/sec
Standard Deviation 0.26
|
|
Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
After 4 months
|
0.36 kg/sec
Standard Deviation 0.17
|
0.33 kg/sec
Standard Deviation 0.16
|
0.35 kg/sec
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Hemoglobin level was measured to assess the iron status in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin Level After 4 Months
At Baseline
|
12.9 gram per decilitre (g/dl)
Interval 12.3 to 13.4
|
12.94 gram per decilitre (g/dl)
Interval 12.5 to 13.6
|
12.88 gram per decilitre (g/dl)
Interval 12.3 to 13.48
|
|
Change From Baseline in Hemoglobin Level After 4 Months
After 4 months
|
12.7 gram per decilitre (g/dl)
Interval 12.0 to 13.1
|
12.60 gram per decilitre (g/dl)
Interval 11.8 to 13.3
|
12.60 gram per decilitre (g/dl)
Interval 12.05 to 13.15
|
|
Change From Baseline in Hemoglobin Level After 4 Months
Change from baseline after 4 months
|
-0.20 gram per decilitre (g/dl)
Interval -0.7 to 0.2
|
-0.31 gram per decilitre (g/dl)
Interval -0.8 to 0.1
|
-0.20 gram per decilitre (g/dl)
Interval -0.7 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Ferritin level was measured to assess the iron status of study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Ferritin Level After 4 Months
At Baseline
|
27.59 nanogram per mililitre (ng/mL)
Interval 17.32 to 45.46
|
20.17 nanogram per mililitre (ng/mL)
Interval 13.14 to 28.96
|
24.48 nanogram per mililitre (ng/mL)
Interval 16.88 to 39.76
|
|
Change From Baseline in Ferritin Level After 4 Months
After 4 months
|
38.78 nanogram per mililitre (ng/mL)
Interval 29.06 to 54.95
|
23.89 nanogram per mililitre (ng/mL)
Interval 14.58 to 34.34
|
25.79 nanogram per mililitre (ng/mL)
Interval 16.92 to 36.92
|
|
Change From Baseline in Ferritin Level After 4 Months
Change from baseline after 4 months
|
9.36 nanogram per mililitre (ng/mL)
Interval 2.42 to 17.61
|
1.94 nanogram per mililitre (ng/mL)
Interval -1.18 to 8.89
|
0.17 nanogram per mililitre (ng/mL)
Interval -5.44 to 6.64
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
At Baseline
|
5.91 miligram per litre (mg/L)
Interval 5.27 to 7.16
|
6.20 miligram per litre (mg/L)
Interval 5.56 to 7.34
|
5.98 miligram per litre (mg/L)
Interval 5.29 to 6.94
|
|
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
After 4 months
|
5.75 miligram per litre (mg/L)
Interval 5.11 to 6.65
|
5.99 miligram per litre (mg/L)
Interval 5.18 to 7.48
|
6.01 miligram per litre (mg/L)
Interval 5.35 to 6.56
|
|
Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
Change from baseline after 4 months
|
-0.33 miligram per litre (mg/L)
Interval -0.95 to 0.2
|
-0.24 miligram per litre (mg/L)
Interval -0.69 to 0.24
|
-0.02 miligram per litre (mg/L)
Interval -0.4 to 0.43
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
C-reactive protein level was measured.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in C-reactive Protein Level After 4 Months
At Baseline
|
0.20 mg/L
Interval 0.0 to 0.7
|
0.30 mg/L
Interval 0.0 to 0.78
|
0.40 mg/L
Interval 0.0 to 0.8
|
|
Change From Baseline in C-reactive Protein Level After 4 Months
After 4 months
|
0.40 mg/L
Interval 0.0 to 0.8
|
0.20 mg/L
Interval 0.0 to 0.8
|
0.40 mg/L
Interval 0.1 to 0.7
|
|
Change From Baseline in C-reactive Protein Level After 4 Months
Change from baseline after 4 months
|
0 mg/L
Interval -0.2 to 0.4
|
0 mg/L
Interval -0.5 to 0.3
|
0 mg/L
Interval -0.4 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Vitamin B2 Level After 4 Months
At Baseline
|
1.56 ratio
Interval 1.47 to 1.64
|
1.52 ratio
Interval 1.43 to 1.61
|
1.57 ratio
Interval 1.48 to 1.7
|
|
Change From Baseline in Vitamin B2 Level After 4 Months
After 4 months
|
1.22 ratio
Interval 1.17 to 1.28
|
1.47 ratio
Interval 1.41 to 1.56
|
1.56 ratio
Interval 1.47 to 1.69
|
|
Change From Baseline in Vitamin B2 Level After 4 Months
Change from baseline after 4 months
|
-0.32 ratio
Interval -0.41 to -0.26
|
-0.04 ratio
Interval -0.1 to 0.0
|
0.00 ratio
Interval -0.08 to 0.07
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Vitamin B6 level was measured as micronutrient markers in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Vitamin B6 Level After 4 Months
At Baseline
|
33.77 nano mole per litre (nmol/L)
Interval 20.71 to 50.3
|
34.28 nano mole per litre (nmol/L)
Interval 22.44 to 50.66
|
39.27 nano mole per litre (nmol/L)
Interval 21.76 to 51.98
|
|
Change From Baseline in Vitamin B6 Level After 4 Months
After 4 months
|
59.66 nano mole per litre (nmol/L)
Interval 39.62 to 79.15
|
37.79 nano mole per litre (nmol/L)
Interval 27.02 to 50.14
|
39.77 nano mole per litre (nmol/L)
Interval 24.29 to 61.77
|
|
Change From Baseline in Vitamin B6 Level After 4 Months
Change from baseline after 4 months
|
23.96 nano mole per litre (nmol/L)
Interval 6.74 to 45.0
|
4.72 nano mole per litre (nmol/L)
Interval -5.36 to 16.14
|
2.52 nano mole per litre (nmol/L)
Interval -11.02 to 19.6
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Vitamin B12 Level After 4 Months
After 4 months
|
427.82 picomole per litre(pmol/L)
Interval 348.71 to 565.46
|
218.30 picomole per litre(pmol/L)
Interval 171.22 to 315.05
|
220.44 picomole per litre(pmol/L)
Interval 158.56 to 272.99
|
|
Change From Baseline in Vitamin B12 Level After 4 Months
At Baseline
|
210.03 picomole per litre(pmol/L)
Interval 166.77 to 285.74
|
213.02 picomole per litre(pmol/L)
Interval 163.21 to 296.66
|
224.02 picomole per litre(pmol/L)
Interval 164.41 to 270.24
|
|
Change From Baseline in Vitamin B12 Level After 4 Months
Change from baseline after 4 months
|
210.77 picomole per litre(pmol/L)
Interval 164.64 to 266.12
|
5.31 picomole per litre(pmol/L)
Interval -25.9 to 28.86
|
-10.11 picomole per litre(pmol/L)
Interval -39.37 to 15.35
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Folate level was measured as micronutrient markers in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Folate Level After 4 Months
At Baseline
|
583.68 nanogram per mililitre (ng/mL)
Interval 532.68 to 669.43
|
585.29 nanogram per mililitre (ng/mL)
Interval 543.79 to 644.0
|
592.82 nanogram per mililitre (ng/mL)
Interval 510.63 to 684.32
|
|
Change From Baseline in Folate Level After 4 Months
After 4 months
|
1013.40 nanogram per mililitre (ng/mL)
Interval 878.96 to 1147.08
|
592.41 nanogram per mililitre (ng/mL)
Interval 533.26 to 647.71
|
592.93 nanogram per mililitre (ng/mL)
Interval 510.63 to 688.04
|
|
Change From Baseline in Folate Level After 4 Months
Change from baseline after 4 months
|
396.97 nanogram per mililitre (ng/mL)
Interval 286.74 to 496.87
|
-13.03 nanogram per mililitre (ng/mL)
Interval -49.56 to 40.02
|
-9.62 nanogram per mililitre (ng/mL)
Interval -56.45 to 48.42
|
SECONDARY outcome
Timeframe: Baseline, after 4 monthsPopulation: Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Vitamin C level was measured as micronutrient markers in study participants.
Outcome measures
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 Participants
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 Participants
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 Participants
Participants were not administered with any intervention.
|
|---|---|---|---|
|
Change From Baseline in Vitamin C Level After 4 Months
At Baseline
|
0.69 miligram per decilitre (mg/dL)
Interval 0.43 to 1.04
|
0.61 miligram per decilitre (mg/dL)
Interval 0.41 to 0.98
|
0.72 miligram per decilitre (mg/dL)
Interval 0.45 to 1.23
|
|
Change From Baseline in Vitamin C Level After 4 Months
After 4 months
|
1.49 miligram per decilitre (mg/dL)
Interval 1.2 to 1.75
|
0.77 miligram per decilitre (mg/dL)
Interval 0.46 to 1.19
|
0.76 miligram per decilitre (mg/dL)
Interval 0.43 to 1.21
|
|
Change From Baseline in Vitamin C Level After 4 Months
Change from baseline after 4 months
|
0.83 miligram per decilitre (mg/dL)
Interval 0.48 to 1.09
|
0.13 miligram per decilitre (mg/dL)
Interval -0.33 to 0.45
|
0.09 miligram per decilitre (mg/dL)
Interval -0.46 to 0.44
|
Adverse Events
Experimental Group (Fortified Nutritional Supplement)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Control Group A (Unfortified Nutritional Powder)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Control Group B (No Intervention)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group (Fortified Nutritional Supplement)
n=100 participants at risk
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group A (Unfortified Nutritional Powder)
n=100 participants at risk
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
|
Control Group B (No Intervention)
n=100 participants at risk
Participants were not administered with any intervention.
|
|---|---|---|---|
|
General disorders
Vomiting
|
5.0%
5/100
General Disorders adverse events (AEs) terms are not coded.
|
2.0%
2/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Loose stools
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Skin allergy
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
2.0%
2/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Abdominal pain
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Excessive tiredness after 20m shuttle
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Abrasion during 20 m shuttle
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Felt dizzy after blood collection
|
2.0%
2/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Fever
|
14.0%
14/100
General Disorders adverse events (AEs) terms are not coded.
|
8.0%
8/100
General Disorders adverse events (AEs) terms are not coded.
|
3.0%
3/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Otitis media
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Urinary tract infection
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Abrasion
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Fall/Fracture
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Chicken pox
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Leg wound
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Scabies
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Tooth ache
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
2.0%
2/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Respiratory tract infection
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Ear/leg pain
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
General disorders
Perianal abscess
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
|
Gastrointestinal disorders
Insect bite
|
1.0%
1/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
0.00%
0/100
General Disorders adverse events (AEs) terms are not coded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER