Trial Outcomes & Findings for A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children (NCT NCT02542865)

Last Updated: 2019-12-05

Results Overview

Number of days a participant was ill due to GI and/or respiratory illness as diagnosed by physician, as per criteria defined, over the intervention duration. This equals total number of days (symptomatic or asymptomatic) in illnesses episodes whereas each episode is defined as an incidence of illness followed by at least 3 symptoms free days. GI illness was defined as an acute illness that includes any of following symptoms:3 or more loose/liquid/watery stools and/or vomiting in 24hours (h). Respiratory illness was defined as an acute illness that included more than or equal to \[\>=\] 1 of the following symptoms: runny nose, stuffy or blocked nose, cough fever or chills, sore throat or sneezing.

Recruitment status

COMPLETED

Study phase

Target enrollment

924 participants

Primary outcome timeframe

At month 9

Results posted on

2019-12-05

Participant Flow

Participants were recruited from 4 schools in India.

Total 958 participants were screened. Of these, 924 participants were enrolled for randomized treatment, of which, 2 participants withdrew their consent before starting the treatment. 34 participants were not enrolled, of which, 11 did not meet study criteria, 22 had withdrawal of consent and 1 identified as screen failure.

Participant milestones

Participant milestones
Measure	Fortified Malt Based Food Plus Dietary Counselling In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Overall Study STARTED	462	462
Overall Study Treated	460	462
Overall Study COMPLETED	445	462
Overall Study NOT COMPLETED	17	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fortified Malt Based Food Plus Dietary Counselling In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Overall Study Identified as screen failure	1	0
Overall Study Withdrawal by Subject	16	0

Baseline Characteristics

A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fortified Malt Based Food Plus Dietary Counselling n=460 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.	Total n=922 Participants Total of all reporting groups
Age, Continuous	8.0 Years STANDARD_DEVIATION 0.78 • n=5 Participants	7.9 Years STANDARD_DEVIATION 0.84 • n=7 Participants	8.0 Years STANDARD_DEVIATION 0.81 • n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants	206 Participants n=7 Participants	402 Participants n=5 Participants
Sex: Female, Male Male	264 Participants n=5 Participants	256 Participants n=7 Participants	520 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	460 Participants n=5 Participants	462 Participants n=7 Participants	922 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	120.83 Centimeters (cm) STANDARD_DEVIATION 4.804 • n=5 Participants	120.71 Centimeters (cm) STANDARD_DEVIATION 5.070 • n=7 Participants	120.77 Centimeters (cm) STANDARD_DEVIATION 4.937 • n=5 Participants
Weight	22.66 Kilograms (kg) STANDARD_DEVIATION 4.053 • n=5 Participants	22.14 Kilograms (kg) STANDARD_DEVIATION 4.565 • n=7 Participants	22.40 Kilograms (kg) STANDARD_DEVIATION 4.323 • n=5 Participants

PRIMARY outcome

Timeframe: At month 9

Population: mITT (modified intent-to-treat) population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9	2.3 Number of days Standard Deviation 5.23	8.2 Number of days Standard Deviation 7.97

SECONDARY outcome

Timeframe: At month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Number of episodes of GI and respiratory illnesses was calculated at month 9 using a diagnosis form (DF) which were used to note the diagnosis, severity, and school absenteeism due to GI and respiratory illnesses only, as defined in the study protocol. The DF captured the start and end date of all occurrences of GI and respiratory illnesses in the week. The frequency was calculated as total number of GI and respiratory illness episodes, divided by duration of intervention, where each episode is defined as each incidence of illness followed by at least uninterrupted 3 symptom free days. Therefore, the formula for calculation used was: frequency (per month) = number of episodes multiply (x) 30 and divided by (/) number of days between first and last visit.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Frequency of GI and Respiratory Illnesses at Month 9	0.067 Number of episodes per month Standard Deviation 0.1100	0.241 Number of episodes per month Standard Deviation 0.1584

SECONDARY outcome

Timeframe: At month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Severity of GI illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade: classified as, diarrhea (Mild, increase of less than \[\<\] 4 stools per \[/\] day over baseline; Moderate, increase of 4 to 6 stools/day over baseline; Severe, increase of more than or equal to \[\>=\]7 loose stools/day over baseline) and vomiting (1-2 episodes, separated by 5 minutes\[min\] in 24 h; Moderate, 3-5 episodes, separated by 5 min in 24 h; Severe, \>=6 episodes, separated by 5 min in 24 h. The count of participants was calculated based on the episode of worst severity. Lower severity indicates no illness of participant.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Severity of GI Illnesses at Month 9 Mild	30 Participants	163 Participants
Severity of GI Illnesses at Month 9 Moderate	13 Participants	20 Participants
Severity of GI Illnesses at Month 9 Severe	0 Participants	0 Participants
Severity of GI Illnesses at Month 9 No illness	402 Participants	279 Participants

SECONDARY outcome

Timeframe: At month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Intensity of respiratory illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade classified as, Mild or Grade1 is asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate or Grade 2 is minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Instrumental ADL refer to school attendance, playing, studying, participating in school activities; and Severe or Grade 3 and 4: Grade 3 is severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden; Grade 4 is life-threatening consequences; urgent indication indicated.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Severity of Respiratory Illnesses at Month 9 Mild	97 Participants	293 Participants
Severity of Respiratory Illnesses at Month 9 Moderate	50 Participants	89 Participants
Severity of Respiratory Illnesses at Month 9 Severe	12 Participants	8 Participants
Severity of Respiratory Illnesses at Month 9 No illness	286 Participants	72 Participants

SECONDARY outcome

Timeframe: At month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

School absenteeism was calculated as number of days when a participant failed to attend school because of GI and/or respiratory illnesses. DF was used to note school absenteeism , however it was marked for absenteeism due to GI and respiratory illnesses only.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9	0.1 Number of days Standard Deviation 0.61	0.6 Number of days Standard Deviation 1.34

SECONDARY outcome

Timeframe: At screening and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Change in Body Mass Index (BMI) was calculated at month 9 using anthropometric measurements. For measuring participant's height, portable stadio-meter was used with the participant standing barefoot; to the nearest 0.1 centimeters (cm) and average of 3 measurements were recorded. All data recorded in cm were converted to meters (m) for BMI calculation. For measuring participant's weight, standardized weighing scale was used in standard clothing to the nearest 0.1kilograms (kg) and average of 3 measurements were recorded. BMI value was calculated using the formula weight divided by square of height (weight \[kilogram (kg)/ Height \[meter (m)\]\^2)

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Body Mass Index (BMI) at Month 9 At month 9	15.668 Kilograms per meter square (kg/m^2) Standard Deviation 2.3446	15.187 Kilograms per meter square (kg/m^2) Standard Deviation 2.3620
Change From Baseline in Body Mass Index (BMI) at Month 9 Change from baseline at month 9	0.194 Kilograms per meter square (kg/m^2) Standard Deviation 0.9948	0.068 Kilograms per meter square (kg/m^2) Standard Deviation 1.4408

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Improvement in gut wall integrity was considered a possible factor to assess the micronutrient absorption. Lactulose mannitol test was used to evaluate change in gut wall permeability status to assess impact on micronutrient absorption. After 3h of fasting, pre-measured amount of lactulose/mannitol solution (2 milliliter/Kilogram \[mL/Kg\] of body weight) containing lactulose (250 milligram/milliliter \[mg/mL\])\] and mannitol (50 mg/mL) was administered as a test solution. Participants were allowed to return to their regular diet 30 minutes after ingestion of the test solution. During the 2.5 h time, participants were offered liquids frequently in order to permit collection of an adequate volume of urine. After 2.5 h, urine collection was performed. All urine passed over duration of 2.5 h was collected and analysed. High Performance Liquid Chromatography (HPLC) test method was used to measure the levels. The normal range of urinary lactulose: mannitol is less than \[\<\] 0.035.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9 At baseline	0.0504 Ratio (unitless) Standard Deviation 0.19891	0.0218 Ratio (unitless) Standard Deviation 0.01150
Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9 At month 9	0.0429 Ratio (unitless) Standard Deviation 0.06399	0.0405 Ratio (unitless) Standard Deviation 0.12221
Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9 Change from baseline at month 9	-0.0082 Ratio (unitless) Standard Deviation 0.21151	0.0192 Ratio (unitless) Standard Deviation 0.12400

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Improvement in gut wall integrity was considered a possible factor to assess the micronutrient absorption. Neopterin test was used to evaluate change in gut wall permeability status to assess impact on micronutrient absorption. Spontaneous random urine was collected from the participants and a volume of 2mL per participant was stored and analysed. Urine sample for this test were collected prior to administration of Lactulose/Mannitol solution. Enzyme-linked immunosorbent assay (ELISA) test method was used to measure the levels. The values were measured in Millimoles per moles of creatinin (mmol/mol creatinin). The normal range of urinary neopterin is 0.10-5.00 mmol/ mol creatinin.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9 At month 9	0.537 mmol/mol creatinin Standard Deviation 0.4955	0.557 mmol/mol creatinin Standard Deviation 0.4937
Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9 Change from baseline at month 9	0.119 mmol/mol creatinin Standard Deviation 0.6188	0.169 mmol/mol creatinin Standard Deviation 0.6302
Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9 At baseline	0.419 mmol/mol creatinin Standard Deviation 0.3967	0.388 mmol/mol creatinin Standard Deviation 0.4410

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of salivary IgA was used to measure the impact of fortified malt based food on mucosal immunity. Saliva was collected using saliva collection aid (SCA). Ribbed-end of the SCA were securely placed into a pre-labeled collection vial. Participants were instructed to pool the saliva in mouth. SCA was placed on mouth entry. Then, participants were asked to tilt the head forward, and gently force saliva through the SCA into the vial to fill with at least 50 microliters (mcL) of volume. A small amount of air space was reserved in the vial to accommodate liquid expansion during freezing. After collection of sample, SCA was removed and discarded and cap was attached to collection vial and tightened. ELISA test method was used to detect the salivary IgA levels. The normal range of salivary IgA is 25.00-168.00 milligrams per liter (mg/L).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9 At baseline	84.659 mg/L Standard Deviation 33.7306	79.278 mg/L Standard Deviation 33.3108
Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9 At month 9	94.392 mg/L Standard Deviation 29.3311	90.386 mg/L Standard Deviation 29.2448
Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9 Change from baseline at month 9	9.733 mg/L Standard Deviation 25.7247	11.108 mg/L Standard Deviation 24.9461

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of micronutrients, serum vitamin-A and of trace elements Zn, Cu and Fe levels in serum were used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test methods used were ELISA for vitamin-A and colorimetric assays for Zn, Cu and Fe as 5-Br-PAPS; 3,5-Dibromo-PAES and TPTZ, respectively. The normal range of serum Vitamin-A is 26.00-49.00 micrograms per deciliter (mcg/dL) and serum Zn is 78.00-105.00 (male and females aged 7-9 years), 78.00- 118.00 (females aged 10 years) and 78.00-98.00 (males aged 10 years) mcg/dL. The normal range of serum Cu is 51.00-121.00 mcg/dL and serum Fe is 50.00-120.00 mcg/dL.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Vitamin-A : at baseline	29.522 mcg/dL Standard Deviation 6.3004	28.141 mcg/dL Standard Deviation 5.4046
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Vitamin-A : at month 9	31.631 mcg/dL Standard Deviation 7.4251	31.446 mcg/dL Standard Deviation 6.5425
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Vitamin-A : change from baseline at month 9	2.109 mcg/dL Standard Deviation 8.0874	3.305 mcg/dL Standard Deviation 7.4460
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Zn: at baseline	72.166 mcg/dL Standard Deviation 19.8017	72.583 mcg/dL Standard Deviation 19.9806
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Zn: at month 9	88.795 mcg/dL Standard Deviation 22.4039	89.450 mcg/dL Standard Deviation 23.1540
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Zn: change from baseline at month 9	16.629 mcg/dL Standard Deviation 19.8966	16.867 mcg/dL Standard Deviation 19.6339
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Cu: at baseline	117.896 mcg/dL Standard Deviation 15.9230	117.771 mcg/dL Standard Deviation 16.0825
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Cu: at month 9	116.514 mcg/dL Standard Deviation 19.2957	116.996 mcg/dL Standard Deviation 18.0636
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Cu: change from baseline at month 9	-1.382 mcg/dL Standard Deviation 19.0421	-0.775 mcg/dL Standard Deviation 19.3061
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Fe: at baseline	70.087 mcg/dL Standard Deviation 29.7686	71.426 mcg/dL Standard Deviation 29.1396
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Fe: at month 9	70.843 mcg/dL Standard Deviation 23.5478	70.349 mcg/dL Standard Deviation 21.7732
Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9 Serum Fe: change from baseline at month 9	0.755 mcg/dL Standard Deviation 27.2156	-1.077 mcg/dL Standard Deviation 24.7602

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of the trace element, serum Se was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method used was inductively coupled plasma mass spectrometry (ICP-MS). The normal range of serum Se is 55.00-134.00 micrograms per liter (mcg/L).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9 Serum Selenium: at baseline	83.625 mcg/L Standard Deviation 12.6082	85.905 mcg/L Standard Deviation 12.2420
Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9 Serum Selenium: at month 9	92.703 mcg/L Standard Deviation 17.5743	91.286 mcg/L Standard Deviation 17.0242
Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9 Serum Selenium: change from baseline at month 9	9.078 mcg/L Standard Deviation 17.2151	5.381 mcg/L Standard Deviation 17.0555

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of micronutrient, serum vitamin-B12 was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of the serum vitamin B12 is 312.00-1237.00 is picograms per milliliter (pg/mL).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9 At baseline	374.384 pg/mL Standard Deviation 87.3163	375.671 pg/mL Standard Deviation 97.5075
Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9 At month 9	429.682 pg/mL Standard Deviation 85.4784	419.310 pg/mL Standard Deviation 91.2245
Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9 Change from baseline at month 9	55.299 pg/mL Standard Deviation 80.1776	43.638 pg/mL Standard Deviation 78.1703

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of serum vitamin-D (25-hydroxycholecalciferol) and serum folate micronutrients were used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of serum Vitamin-D is 30.00-100.00 nanograms per milliliter (ng/mL) and serum folate is 5.00-21.00 ng/mL.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum Vitamin-D: at baseline	17.479 ng/mL Standard Deviation 5.6318	17.893 ng/mL Standard Deviation 5.1043
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum Vitamin-D: at month 9	20.329 ng/mL Standard Deviation 5.7833	20.054 ng/mL Standard Deviation 5.0556
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum Vitamin-D: change in baseline at month 9	2.850 ng/mL Standard Deviation 4.9529	2.161 ng/mL Standard Deviation 4.8962
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum folate: at baseline	4.510 ng/mL Standard Deviation 0.7322	4.415 ng/mL Standard Deviation 0.7075
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum folate: at month 9	5.171 ng/mL Standard Deviation 0.7914	5.070 ng/mL Standard Deviation 0.8106
Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9 Serum folate: change from baseline at month 9	0.661 ng/mL Standard Deviation 0.7897	0.656 ng/mL Standard Deviation 0.7631

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of micronutrient, serum vitamin-E was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of serum vitamin-E is 0.30-0.90 milligrams per deciliter (mg/dL).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9 At month 9	0.541 mg/dL Standard Deviation 0.1407	0.494 mg/dL Standard Deviation 0.1145
Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9 At baseline	0.493 mg/dL Standard Deviation 0.1435	0.475 mg/dL Standard Deviation 0.1616
Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9 Change from baseline at month 9	0.048 mg/dL Standard Deviation 0.1549	0.018 mg/dL Standard Deviation 0.1452

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantitative analysis of serum ferritin was studied to measure iron status. Its value was adjusted by other acute phase proteins such as C-reactive protein (CRP) and Alpha 1-acid glycoprotein (AGP) which are not related to iron status and played a role as a part of assessment on inflammatory status and to adjust ferritin status. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The turbidimetry test method was used to measure the levels.The normal range of serum ferritin is 7.00-140.00 nanograms per milliliter (ng/ml).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9 At baseline	24.261 ng/ml Standard Deviation 18.3705	22.743 ng/ml Standard Deviation 13.5996
Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9 At month 9	27.239 ng/ml Standard Deviation 12.7525	25.223 ng/ml Standard Deviation 13.6193
Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9 Change from baseline at month 9	2.978 ng/ml Standard Deviation 19.4921	2.480 ng/ml Standard Deviation 16.1006

SECONDARY outcome

Timeframe: At baseline and month 9

Quantitative analysis of sTfR along with serum iron and serum ferritin was studied to measure iron status. In cases of a high prevalence of infection and inflammation, sTfR becomes the choice of iron status marker. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The immunoturbidimetry test method was used to measure the levels. The normal range of sTfR is 1.90-4.40 milligrams per liter (mg/L).

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9 At baseline	1.564 mg/L Standard Deviation 0.5009	1.521 mg/L Standard Deviation 0.4937
Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9 At month 9	1.510 mg/L Standard Deviation 0.3670	1.471 mg/L Standard Deviation 0.3483
Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9 Change from baseline at month 9	-0.055 mg/L Standard Deviation 0.4181	-0.050 mg/L Standard Deviation 0.3594

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantitative analysis of acute phase proteins such as serum CRP and serum AGP were studied to assess inflammatory status and adjust ferritin status. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The immunoturbidimetry test method was used to measure the levels of CRP and turbidimetry for AGP. The normal range of the serum CRP is less than (\<) 0.50 milligrams per deciliter (mg/dL) and serum AGP is 50.00-120.00 mg/dL.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 AGP: at month 9	74.972 mg/dL Standard Deviation 18.8386	74.219 mg/dL Standard Deviation 16.9083
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 CRP: at baseline	0.057 mg/dL Standard Deviation 0.1978	0.046 mg/dL Standard Deviation 0.1466
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 CRP: at month 9	0.114 mg/dL Standard Deviation 0.2117	0.103 mg/dL Standard Deviation 0.1839
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 CRP: change from baseline at month 9	0.058 mg/dL Standard Deviation 0.2682	0.057 mg/dL Standard Deviation 0.1916
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 AGP: at baseline	74.888 mg/dL Standard Deviation 20.4840	74.542 mg/dL Standard Deviation 18.0323
Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9 AGP: change from baseline at month 9	0.083 mg/dL Standard Deviation 18.8226	-0.323 mg/dL Standard Deviation 16.7025

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

IDDS-measure of nutritional quality of individual's diet-assessed by questionnaire based on Guidelines for measuring household and individual dietary diversity set by Food and Agriculture Organisation (FAO) of United Nations\[FAO guidelines dietary diversity,2011\].Based on data of foods and beverages consumed in last 24h as captured by 24h dietary survey,appropriate food groups were selected. IDDS was calculated by adding number of food groups consumed by child over 24h recall period. Scoring 0-9with 1 point for foods that were consumed from each of food groups in previous 24h:starchy staples,dark green leafy vegetables,other vitamin A rich fruits and vegetables,other fruits and vegetables,organ meat, meat and fish, eggs, legumes, nuts, and seeds, milk and milk products. Based on IDDS,participants were listed into 3 food groups: a) less than or equal to \[\<=\]3-low dietary diversity (DD);b)4-5-medium DD;c) greater than or equal to \[\>=\]6-high DD. High score indicates nutrition rich food.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9 At baseline	4.2 Diversity score Standard Deviation 0.71	4.4 Diversity score Standard Deviation 0.67
Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9 At month 9	5.7 Diversity score Standard Deviation 1.23	4.6 Diversity score Standard Deviation 0.76
Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9 Change from baseline at month 9	1.5 Diversity score Standard Deviation 1.54	0.3 Diversity score Standard Deviation 0.99

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of dietary intake was measured by protein, carbohydrate, and fat intake which was assessed from 24h dietary recall form. A structured interview was conducted based on a questionnaire. Parent/LARs provided the majority of information, with the child/ participant making additions to fill in the gaps. Both participants and parents/LARs recalled all food and beverage consumed by the child during previous 24h and information such as list and amount of ingredients, cooking method and portion size was recorded. Calculation on energy, protein, carbohydrates and fat were made using Dietsoft software based on Indian data (NIN \[National Institute of Nutrition\] and ICMR \[Indian Council of Medical Research\]) was used.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Protein: at baseline	38.840 Grams (g) Standard Deviation 11.8775	42.406 Grams (g) Standard Deviation 13.3945
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Protein: at month 9	46.556 Grams (g) Standard Deviation 11.7492	38.341 Grams (g) Standard Deviation 11.0772
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Protein: change from baseline at month 9	7.716 Grams (g) Standard Deviation 17.3205	-4.065 Grams (g) Standard Deviation 16.5706
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Carbohydrate: at baseline	189.478 Grams (g) Standard Deviation 50.7510	202.385 Grams (g) Standard Deviation 55.0813
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Carbohydrate: at month 9	186.223 Grams (g) Standard Deviation 42.4576	181.126 Grams (g) Standard Deviation 47.6042
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Carbohydrate: change from baseline at month 9	-3.255 Grams (g) Standard Deviation 67.6676	-21.259 Grams (g) Standard Deviation 74.4880
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Fat: at baseline	47.516 Grams (g) Standard Deviation 16.5686	40.034 Grams (g) Standard Deviation 16.4056
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Fat: at month 9	59.006 Grams (g) Standard Deviation 18.0862	40.210 Grams (g) Standard Deviation 16.2262
Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9 Fat: change from baseline at month 9	11.490 Grams (g) Standard Deviation 23.3769	0.175 Grams (g) Standard Deviation 20.6106

SECONDARY outcome

Timeframe: At baseline and month 9

Population: mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.

Quantity of dietary intake was also measured by energy intake which was assessed from 24-h dietary recall survey. A structured interview was conducted based on a questionnaire. Parent/LARs (legally appropriate representative) provided the majority of information, with the child making additions to fill in the gaps. Parents/LARs recalled all food and beverage consumed by the child during previous 24-h and information such as list and amount of ingredients, cooking method and portion size was recorded. Calculation on energy, protein, carbohydrates and fat were made using Dietsoft software based on Indian data (NIN and ICMR) was used.

Outcome measures

Outcome measures
Measure	Fortified Malt Based Food Plus Dietary Counselling n=445 Participants In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs \[legally acceptable representative\]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.	Dietary Counselling Only n=462 Participants In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
Change From Baseline in Energy Consumption at Month 9 At baseline	1395.142 Kilocalories (Kcal) Standard Deviation 305.7777	1406.079 Kilocalories (Kcal) Standard Deviation 352.7524
Change From Baseline in Energy Consumption at Month 9 At month 9	1496.411 Kilocalories (Kcal) Standard Deviation 299.0027	1309.889 Kilocalories (Kcal) Standard Deviation 325.2896
Change From Baseline in Energy Consumption at Month 9 Change from baseline at month 9	101.269 Kilocalories (Kcal) Standard Deviation 446.1953	-96.190 Kilocalories (Kcal) Standard Deviation 484.0124

Adverse Events

Fortified Malt Based Food Plus Dietary Counselling

Serious events: 0 serious events

Other events: 214 other events

Deaths: 0 deaths

Dietary Counselling Only

Serious events: 0 serious events

Other events: 435 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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