Nutritional Status, Physical Fitness
Conditions
Keywords
physical performance, micronutrients, physical fitness, healthy children
Brief 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.
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.
Interventions
OTHERNutritional supplement
Fortified nutritional powder
OTHERPlacebo
Un-fortified nutritional powder
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ferritin Level After 4 Months | Baseline, after 4 months | Ferritin level was measured to assess the iron status of study participants. |
| Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | Baseline, after 4 months | Soluble transferring receptors (sTr) was measured to assess the iron status of study participants. |
| Change From Baseline in C-reactive Protein Level After 4 Months | Baseline, after 4 months | C-reactive protein level was measured. |
| Change From Baseline in Vitamin B2 Level After 4 Months | Baseline, after 4 months | Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants. |
| Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Baseline, 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. |
| Change From Baseline in Vitamin B12 Level After 4 Months | Baseline, after 4 months | Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants. |
| Change From Baseline in Folate Level After 4 Months | Baseline, after 4 months | Folate level was measured as micronutrient markers in study participants. |
| Change From Baseline in Vitamin C Level After 4 Months | Baseline, after 4 months | Vitamin C level was measured as micronutrient markers in study participants. |
| Change From Baseline in Vitamin B6 Level After 4 Months | Baseline, after 4 months | Vitamin B6 level was measured as micronutrient markers in study participants. |
| Change From Baseline in Time to Fatigue After 4 Months | Baseline, 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. |
| Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | Baseline, 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). |
| Change From Baseline in Hemoglobin Level After 4 Months | Baseline, after 4 months | Hemoglobin level was measured to assess the iron status in study participants. |
Countries
India
Participant flow
Recruitment details
Participants were recruited from three schools of Karnataka at a clinical site in Karnataka.
Pre-assignment details
A total of 379 participants were screened. Out of which 300 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group (Fortified Nutritional Supplement) 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. | 100 |
| Control Group A (Unfortified Nutritional Powder) 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. | 100 |
| Control Group B (No Intervention) Participants were not administered with any intervention. | 100 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Withdrew Consent due to Adverse Event | 5 | 4 | 2 |
Baseline characteristics
| Characteristic | Experimental Group (Fortified Nutritional Supplement) | Control Group A (Unfortified Nutritional Powder) | Control Group B (No Intervention) | Total |
|---|---|---|---|---|
| Age, Continuous | 8.26 Years STANDARD_DEVIATION 1.02 | 8.18 Years STANDARD_DEVIATION 1.01 | 8.29 Years STANDARD_DEVIATION 1.04 | 8.24 Years STANDARD_DEVIATION 1.02 |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
| Sex: Female, Male Male | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 29 / 100 | 25 / 100 | 8 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | After 4 months | 39.1 km/hr*years | Standard Deviation 4.3 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | At Baseline | 31.6 km/hr*years | Standard Deviation 4.3 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | After 4 months | 38.6 km/hr*years | Standard Deviation 3.7 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | At Baseline | 32.8 km/hr*years | Standard Deviation 4.1 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | Change from baseline after 4 months | 5.74 km/hr*years | Standard Deviation 6.02 |
| Control Group B (No Intervention) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | At Baseline | 32.4 km/hr*years | Standard Deviation 4.2 |
| Control Group B (No Intervention) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | Change from baseline after 4 months | 5.80 km/hr*years | Standard Deviation 3.56 |
| Control Group B (No Intervention) | Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months | After 4 months | 38.2 km/hr*years | Standard Deviation 4.1 |
p-value: 0.002Mann Whitney U test
p-value: 0.003Mann Whitney U test
Primary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | After 4 months | 37.6 mL/kg/min. | Standard Deviation 5.3 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | At Baseline | 37.9 mL/kg/min. | Standard Deviation 5.6 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | Change from baseline after 4 months | -0.25 mL/kg/min. | Standard Deviation 6.23 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | At Baseline | 37.0 mL/kg/min. | Standard Deviation 5.3 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | Change from baseline after 4 months | 0.7 mL/kg/min. | Standard Deviation 5.87 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months | After 4 months | 37.8 mL/kg/min. | Standard Deviation 5.3 |
p-value: 0.004Mann Whitney U test
p-value: 0.147Mann Whitney U test
Primary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | At Baseline | 9.0 seconds (Sec) | Standard Deviation 1.3 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | After 4 months | 8.9 seconds (Sec) | Standard Deviation 1 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | At Baseline | 8.9 seconds (Sec) | Standard Deviation 1 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | Change from baseline after 4 months | -0.05 seconds (Sec) | Standard Deviation 0.93 |
| Control Group B (No Intervention) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | At Baseline | 8.9 seconds (Sec) | Standard Deviation 1 |
| Control Group B (No Intervention) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | Change from baseline after 4 months | -0.26 seconds (Sec) | Standard Deviation 1 |
| Control Group B (No Intervention) | Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months | After 4 months | 8.639 seconds (Sec) | Standard Deviation 1 |
p-value: 0.153Mann Whitney U test
p-value: 0.903Mann Whitney U test
Primary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Visual Reaction Time After 4 Months | After 4 months | 863 milliseconds (msec) | Standard Deviation 144 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Visual Reaction Time After 4 Months | At Baseline | 958 milliseconds (msec) | Standard Deviation 217 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Visual Reaction Time After 4 Months | Change from baseline after 4 months | -94 milliseconds (msec) | Standard Deviation 227 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Visual Reaction Time After 4 Months | After 4 months | 884 milliseconds (msec) | Standard Deviation 122 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Visual Reaction Time After 4 Months | At Baseline | 932 milliseconds (msec) | Standard Deviation 189 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Visual Reaction Time After 4 Months | Change from baseline after 4 months | -46 milliseconds (msec) | Standard Deviation 180 |
| Control Group B (No Intervention) | Change From Baseline in Visual Reaction Time After 4 Months | At Baseline | 939 milliseconds (msec) | Standard Deviation 210 |
| Control Group B (No Intervention) | Change From Baseline in Visual Reaction Time After 4 Months | Change from baseline after 4 months | -72 milliseconds (msec) | Standard Deviation 249 |
| Control Group B (No Intervention) | Change From Baseline in Visual Reaction Time After 4 Months | After 4 months | 864 milliseconds (msec) | Standard Deviation 157 |
p-value: 0.143Mann Whitney U test
p-value: 0.678Mann Whitney U test
Secondary
Change From Baseline in C-reactive Protein Level After 4 Months
C-reactive protein level was measured.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in C-reactive Protein Level After 4 Months | After 4 months | 0.40 mg/L |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in C-reactive Protein Level After 4 Months | At Baseline | 0.20 mg/L |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in C-reactive Protein Level After 4 Months | Change from baseline after 4 months | 0 mg/L |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in C-reactive Protein Level After 4 Months | After 4 months | 0.20 mg/L |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in C-reactive Protein Level After 4 Months | At Baseline | 0.30 mg/L |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in C-reactive Protein Level After 4 Months | Change from baseline after 4 months | 0 mg/L |
| Control Group B (No Intervention) | Change From Baseline in C-reactive Protein Level After 4 Months | At Baseline | 0.40 mg/L |
| Control Group B (No Intervention) | Change From Baseline in C-reactive Protein Level After 4 Months | Change from baseline after 4 months | 0 mg/L |
| Control Group B (No Intervention) | Change From Baseline in C-reactive Protein Level After 4 Months | After 4 months | 0.40 mg/L |
Secondary
Change From Baseline in Ferritin Level After 4 Months
Ferritin level was measured to assess the iron status of study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Ferritin Level After 4 Months | After 4 months | 38.78 nanogram per mililitre (ng/mL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Ferritin Level After 4 Months | At Baseline | 27.59 nanogram per mililitre (ng/mL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Ferritin Level After 4 Months | Change from baseline after 4 months | 9.36 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Ferritin Level After 4 Months | After 4 months | 23.89 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Ferritin Level After 4 Months | At Baseline | 20.17 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Ferritin Level After 4 Months | Change from baseline after 4 months | 1.94 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Ferritin Level After 4 Months | At Baseline | 24.48 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Ferritin Level After 4 Months | Change from baseline after 4 months | 0.17 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Ferritin Level After 4 Months | After 4 months | 25.79 nanogram per mililitre (ng/mL) |
Secondary
Change From Baseline in Folate Level After 4 Months
Folate level was measured as micronutrient markers in study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Folate Level After 4 Months | After 4 months | 1013.40 nanogram per mililitre (ng/mL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Folate Level After 4 Months | At Baseline | 583.68 nanogram per mililitre (ng/mL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Folate Level After 4 Months | Change from baseline after 4 months | 396.97 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Folate Level After 4 Months | After 4 months | 592.41 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Folate Level After 4 Months | At Baseline | 585.29 nanogram per mililitre (ng/mL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Folate Level After 4 Months | Change from baseline after 4 months | -13.03 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Folate Level After 4 Months | At Baseline | 592.82 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Folate Level After 4 Months | Change from baseline after 4 months | -9.62 nanogram per mililitre (ng/mL) |
| Control Group B (No Intervention) | Change From Baseline in Folate Level After 4 Months | After 4 months | 592.93 nanogram per mililitre (ng/mL) |
Secondary
Change From Baseline in Hemoglobin Level After 4 Months
Hemoglobin level was measured to assess the iron status in study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Hemoglobin Level After 4 Months | After 4 months | 12.7 gram per decilitre (g/dl) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Hemoglobin Level After 4 Months | At Baseline | 12.9 gram per decilitre (g/dl) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Hemoglobin Level After 4 Months | Change from baseline after 4 months | -0.20 gram per decilitre (g/dl) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Hemoglobin Level After 4 Months | After 4 months | 12.60 gram per decilitre (g/dl) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Hemoglobin Level After 4 Months | At Baseline | 12.94 gram per decilitre (g/dl) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Hemoglobin Level After 4 Months | Change from baseline after 4 months | -0.31 gram per decilitre (g/dl) |
| Control Group B (No Intervention) | Change From Baseline in Hemoglobin Level After 4 Months | At Baseline | 12.88 gram per decilitre (g/dl) |
| Control Group B (No Intervention) | Change From Baseline in Hemoglobin Level After 4 Months | Change from baseline after 4 months | -0.20 gram per decilitre (g/dl) |
| Control Group B (No Intervention) | Change From Baseline in Hemoglobin Level After 4 Months | After 4 months | 12.60 gram per decilitre (g/dl) |
Secondary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Non-dominant hand,change after 4 months | 0.72 kg | Standard Deviation 2.85 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, At Baseline | 9.4 kg | Standard Deviation 3.7 |
| Control Group A (Unfortified Nutritional Powder) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Non-dominant hand, after 4 months | 9.47 kg | Standard Deviation 3 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, after 4 months | 10.6 kg | Standard Deviation 3 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, change after 4 months | 1.21 kg | Standard Deviation 2.91 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, after 4 months | 10.9 kg | Standard Deviation 3.2 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, change after 4 months | 1.09 kg | Standard Deviation 3.15 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Non-dominant hand,change after 4 months | 1.11 kg | Standard Deviation 2.44 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Non-dominant hand, at Baseline | 8.5 kg | Standard Deviation 3.2 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Dominant hand, At Baseline | 9.8 kg | Standard Deviation 3.4 |
| Control Group B (No Intervention) | Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Non-dominant hand, after 4 months | 9.6 kg | Standard Deviation 2.6 |
Secondary
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).
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | After 4 months | 0.36 kg/sec | Standard Deviation 0.17 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | At Baseline | 0.38 kg/sec | Standard Deviation 0.23 |
| Experimental Group (Fortified Nutritional Supplement) | 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 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | After 4 months | 0.33 kg/sec | Standard Deviation 0.16 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | At Baseline | 0.38 kg/sec | Standard Deviation 0.24 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | Change from baseline after 4 months | -0.05 kg/sec | Standard Deviation 0.27 |
| Control Group B (No Intervention) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | At Baseline | 0.42 kg/sec | Standard Deviation 0.26 |
| Control Group B (No Intervention) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | Change from baseline after 4 months | -0.06 kg/sec | Standard Deviation 0.28 |
| Control Group B (No Intervention) | Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | After 4 months | 0.35 kg/sec | Standard Deviation 0.16 |
Secondary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | After 4 months | 5.75 miligram per litre (mg/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | At Baseline | 5.91 miligram per litre (mg/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | Change from baseline after 4 months | -0.33 miligram per litre (mg/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | After 4 months | 5.99 miligram per litre (mg/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | At Baseline | 6.20 miligram per litre (mg/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | Change from baseline after 4 months | -0.24 miligram per litre (mg/L) |
| Control Group B (No Intervention) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | At Baseline | 5.98 miligram per litre (mg/L) |
| Control Group B (No Intervention) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | Change from baseline after 4 months | -0.02 miligram per litre (mg/L) |
| Control Group B (No Intervention) | Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | After 4 months | 6.01 miligram per litre (mg/L) |
Secondary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Time to Fatigue After 4 Months | After 4 months | 14.71 sec | Standard Deviation 7.2457 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Time to Fatigue After 4 Months | At Baseline | 12.31 sec | Standard Deviation 6.71 |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Time to Fatigue After 4 Months | Change from baseline after 4 months | 2.64 sec | Standard Deviation 6.37 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time to Fatigue After 4 Months | After 4 months | 14.62 sec | Standard Deviation 6.35 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time to Fatigue After 4 Months | At Baseline | 12.36 sec | Standard Deviation 7.66 |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Time to Fatigue After 4 Months | Change from baseline after 4 months | 2.03 sec | Standard Deviation 8.39 |
| Control Group B (No Intervention) | Change From Baseline in Time to Fatigue After 4 Months | At Baseline | 11.13 sec | Standard Deviation 9.85 |
| Control Group B (No Intervention) | Change From Baseline in Time to Fatigue After 4 Months | Change from baseline after 4 months | 2.78 sec | Standard Deviation 6.26 |
| Control Group B (No Intervention) | Change From Baseline in Time to Fatigue After 4 Months | After 4 months | 14.03 sec | Standard Deviation 7.25 |
Secondary
Change From Baseline in Vitamin B12 Level After 4 Months
Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B12 Level After 4 Months | After 4 months | 427.82 picomole per litre(pmol/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B12 Level After 4 Months | At Baseline | 210.03 picomole per litre(pmol/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B12 Level After 4 Months | Change from baseline after 4 months | 210.77 picomole per litre(pmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B12 Level After 4 Months | After 4 months | 218.30 picomole per litre(pmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B12 Level After 4 Months | At Baseline | 213.02 picomole per litre(pmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B12 Level After 4 Months | Change from baseline after 4 months | 5.31 picomole per litre(pmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B12 Level After 4 Months | At Baseline | 224.02 picomole per litre(pmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B12 Level After 4 Months | Change from baseline after 4 months | -10.11 picomole per litre(pmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B12 Level After 4 Months | After 4 months | 220.44 picomole per litre(pmol/L) |
Secondary
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.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B2 Level After 4 Months | After 4 months | 1.22 ratio |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B2 Level After 4 Months | At Baseline | 1.56 ratio |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B2 Level After 4 Months | Change from baseline after 4 months | -0.32 ratio |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B2 Level After 4 Months | After 4 months | 1.47 ratio |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B2 Level After 4 Months | At Baseline | 1.52 ratio |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B2 Level After 4 Months | Change from baseline after 4 months | -0.04 ratio |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B2 Level After 4 Months | At Baseline | 1.57 ratio |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B2 Level After 4 Months | Change from baseline after 4 months | 0.00 ratio |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B2 Level After 4 Months | After 4 months | 1.56 ratio |
Secondary
Change From Baseline in Vitamin B6 Level After 4 Months
Vitamin B6 level was measured as micronutrient markers in study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B6 Level After 4 Months | After 4 months | 59.66 nano mole per litre (nmol/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B6 Level After 4 Months | At Baseline | 33.77 nano mole per litre (nmol/L) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin B6 Level After 4 Months | Change from baseline after 4 months | 23.96 nano mole per litre (nmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B6 Level After 4 Months | After 4 months | 37.79 nano mole per litre (nmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B6 Level After 4 Months | At Baseline | 34.28 nano mole per litre (nmol/L) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin B6 Level After 4 Months | Change from baseline after 4 months | 4.72 nano mole per litre (nmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B6 Level After 4 Months | At Baseline | 39.27 nano mole per litre (nmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B6 Level After 4 Months | Change from baseline after 4 months | 2.52 nano mole per litre (nmol/L) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin B6 Level After 4 Months | After 4 months | 39.77 nano mole per litre (nmol/L) |
Secondary
Change From Baseline in Vitamin C Level After 4 Months
Vitamin C level was measured as micronutrient markers in study participants.
Time frame: Baseline, after 4 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin C Level After 4 Months | At Baseline | 0.69 miligram per decilitre (mg/dL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin C Level After 4 Months | Change from baseline after 4 months | 0.83 miligram per decilitre (mg/dL) |
| Experimental Group (Fortified Nutritional Supplement) | Change From Baseline in Vitamin C Level After 4 Months | After 4 months | 1.49 miligram per decilitre (mg/dL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin C Level After 4 Months | After 4 months | 0.77 miligram per decilitre (mg/dL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin C Level After 4 Months | At Baseline | 0.61 miligram per decilitre (mg/dL) |
| Control Group A (Unfortified Nutritional Powder) | Change From Baseline in Vitamin C Level After 4 Months | Change from baseline after 4 months | 0.13 miligram per decilitre (mg/dL) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin C Level After 4 Months | At Baseline | 0.72 miligram per decilitre (mg/dL) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin C Level After 4 Months | Change from baseline after 4 months | 0.09 miligram per decilitre (mg/dL) |
| Control Group B (No Intervention) | Change From Baseline in Vitamin C Level After 4 Months | After 4 months | 0.76 miligram per decilitre (mg/dL) |