Trial Outcomes & Findings for Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam. (NCT NCT05551637)

NCT ID: NCT05551637

Last Updated: 2025-01-14

Results Overview

Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 600 participants
• Primary outcome timeframe: From date of using the product until the date of first documented improvement, assessed up to 3 months
• Results posted on: 2025-01-14

Participant Flow

Location: Yen Bai Provincial Children's Hospital Recruitment time: August 1st, 2022

Subjects of the initial survey: 600 24-71-month-old children from 5 preschools of 5 communes meeting the criteria of WHZ/BAZ < -0.5 and other criteria. Organize training for staff on methods of collecting data, interview techniques, and nutritional status. Data collection implementation: The data collection schedule is notified to the District Hospital, the Provincial Center for Disease Control, and the health department of each school. Information collection sites are located at 5 schools.

Participant milestones

Measure	Control Group (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group (n=300): Children eat usual dietary and using 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school in 5 days per week (From Monday to Friday) and at home on weekend. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Overall Study STARTED	300	300
Overall Study COMPLETED	299	293
Overall Study NOT COMPLETED	1	7

Reasons for withdrawal

Measure	Control Group (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group (n=300): Children eat usual dietary and using 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school in 5 days per week (From Monday to Friday) and at home on weekend. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Overall Study Lack of Efficacy	0	6
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.

Baseline characteristics by cohort

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=293 Participants (n=300): Children eat the usual dietary and use 2 glasses (49.2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49.2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.	Total n=592 Participants Total of all reporting groups
Age, Customized Age group (by months old) · 24 - 35.9 months	52 Participants n=5 Participants	40 Participants n=7 Participants	92 Participants n=5 Participants
Age, Customized Age group (by months old) · 36 - 47.9 months	68 Participants n=5 Participants	82 Participants n=7 Participants	150 Participants n=5 Participants
Age, Customized Age group (by months old) · 48 - 59.9 months	97 Participants n=5 Participants	104 Participants n=7 Participants	201 Participants n=5 Participants
Age, Customized Age group (by months old) · 60 - 71.9 months	82 Participants n=5 Participants	67 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	141 Participants n=7 Participants	291 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	152 Participants n=7 Participants	301 Participants n=5 Participants
Race/Ethnicity, Customized Schools · Cam Nhan	61 Participants n=5 Participants	67 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Schools · Tan Nguyen	43 Participants n=5 Participants	65 Participants n=7 Participants	108 Participants n=5 Participants
Race/Ethnicity, Customized Schools · Vinh Kien	55 Participants n=5 Participants	44 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized Schools · Vu Linh	63 Participants n=5 Participants	59 Participants n=7 Participants	122 Participants n=5 Participants
Race/Ethnicity, Customized Schools · Yen Thanh	77 Participants n=5 Participants	58 Participants n=7 Participants	135 Participants n=5 Participants
Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Weight for age	-1.66 Z-score STANDARD_DEVIATION 0.69 • n=5 Participants	-1.67 Z-score STANDARD_DEVIATION 0.67 • n=7 Participants	-1.66 Z-score STANDARD_DEVIATION 0.68 • n=5 Participants
Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Height for age	-1.31 Z-score STANDARD_DEVIATION 0.86 • n=5 Participants	-1.36 Z-score STANDARD_DEVIATION 0.79 • n=7 Participants	-1.33 Z-score STANDARD_DEVIATION 0.82 • n=5 Participants
Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Weight for height	-1.32 Z-score STANDARD_DEVIATION 0.58 • n=5 Participants	-1.30 Z-score STANDARD_DEVIATION 0.60 • n=7 Participants	-1.31 Z-score STANDARD_DEVIATION 0.59 • n=5 Participants
Weight	13.43 kilograms STANDARD_DEVIATION 1.99 • n=5 Participants	13.42 kilograms STANDARD_DEVIATION 2.05 • n=7 Participants	13.425 kilograms STANDARD_DEVIATION 2.02 • n=5 Participants
Height	98.34 centimeters STANDARD_DEVIATION 7.86 • n=5 Participants	98.13 centimeters STANDARD_DEVIATION 7.48 • n=7 Participants	98.2 centimeters STANDARD_DEVIATION 7.67 • n=5 Participants
Months of age	50.4 months STANDARD_DEVIATION 12.3 • n=5 Participants	50.3 months STANDARD_DEVIATION 11.5 • n=7 Participants	50.35 months STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: From date of using the product until the date of first documented improvement, assessed up to 3 months

Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=293 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Improvement of Digestive Disorders and Anorexia Nervosa Before intervention (T0)	219 participants	212 participants
Improvement of Digestive Disorders and Anorexia Nervosa After 3 months	175 participants	155 participants

PRIMARY outcome

Timeframe: over 1 and 3 months

Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.

Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced at the centre of the scale. When the balance is stable, read and write the result in kg and an odd number after the comma.

All data will be measured at the time T0 (at baseline) and T3 (after 3 months)

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=298 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Change in Weight (kg) After 2 months (T2)	14.09 kilograms Standard Deviation 2.03	14.35 kilograms Standard Deviation 2.20
Change in Weight (kg) After 3 months (T3)	14.24 kilograms Standard Deviation 2.03	14.52 kilograms Standard Deviation 2.23
Change in Weight (kg) Difference between T1 - T0	0.35 kilograms Standard Deviation 0.46	0.54 kilograms Standard Deviation 0.52
Change in Weight (kg) Before intervention (T0)	13.43 kilograms Standard Deviation 1.99	13.5 kilograms Standard Deviation 2.08
Change in Weight (kg) After 1 month (T1)	13.77 kilograms Standard Deviation 2.06	14.04 kilograms Standard Deviation 2.19
Change in Weight (kg) Difference between T2 - T0	0.66 kilograms Standard Deviation 0.54	0.85 kilograms Standard Deviation 0.59
Change in Weight (kg) Difference between T3 - T0	0.81 kilograms Standard Deviation 0.53	1.01 kilograms Standard Deviation 0.65

PRIMARY outcome

Timeframe: over 1 and 3 months

Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.

Change of average weight for age Z Score using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=298 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Change of Weight for Age Z-score Difference between T1 - T0	0.07 Z-score Standard Deviation 0.27	0.18 Z-score Standard Deviation 0.31
Change of Weight for Age Z-score Difference between T2 - T0	0.18 Z-score Standard Deviation 0.31	0.28 Z-score Standard Deviation 0.33
Change of Weight for Age Z-score Difference between T3 - T0	0.19 Z-score Standard Deviation 0.31	0.29 Z-score Standard Deviation 0.35
Change of Weight for Age Z-score Before intervention (T0)	-1.66 Z-score Standard Deviation 0.70	-1.62 Z-score Standard Deviation 0.73
Change of Weight for Age Z-score After 1 month (T1)	-1.58 Z-score Standard Deviation 0.70	-1.44 Z-score Standard Deviation 0.79
Change of Weight for Age Z-score After 2 months (T2)	-1.47 Z-score Standard Deviation 0.70	-1.34 Z-score Standard Deviation 0.77
Change of Weight for Age Z-score After 3 months (T3)	-1.47 Z-score Standard Deviation 0.71	-1.33 Z-score Standard Deviation 0.79

PRIMARY outcome

Timeframe: over 1 and 3 months

Population: Change of average weight for height Z Score and the difference between before intervention and after the intervention

Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=298 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Change of Weight for Height Z-score Before intervention (T0)	-1.32 Z-score Standard Deviation 0.58	-1.32 Z-score Standard Deviation 0.60
Change of Weight for Height Z-score After 1 month (T1)	-1.13 Z-score Standard Deviation 0.61	-0.98 Z-score Standard Deviation 0.68
Change of Weight for Height Z-score After 2 months (T2)	-1.03 Z-score Standard Deviation 0.62	-0.89 Z-score Standard Deviation 0.66
Change of Weight for Height Z-score After 3 months (T3)	-0.96 Z-score Standard Deviation 0.60	-0.84 Z-score Standard Deviation 0.66
Change of Weight for Height Z-score Difference between T1 - T0	0.19 Z-score Standard Deviation 0.40	0.35 Z-score Standard Deviation 0.47
Change of Weight for Height Z-score Difference between T2 - T0	0.29 Z-score Standard Deviation 0.45	0.43 Z-score Standard Deviation 0.51
Change of Weight for Height Z-score Difference between T3 - T0	0.36 Z-score Standard Deviation 0.46	0.48 Z-score Standard Deviation 0.53

PRIMARY outcome

Timeframe: over 1 and 3 months

Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.

A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in cm and an odd number after the comma.

All data will be measured at the time T0 (at baseline) and T3 (after 3 months)

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=298 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Change in Height (cm) Before intervention (T0)	98.34 centimeters Standard Deviation 7.86	98.62 centimeters Standard Deviation 7.86
Change in Height (cm) After 1 month (T1)	98.88 centimeters Standard Deviation 7.89	99.14 centimeters Standard Deviation 7.88
Change in Height (cm) After 2 months (T2)	99.68 centimeters Standard Deviation 7.72	99.96 centimeters Standard Deviation 7.92
Change in Height (cm) After 3 months (T3)	99.95 centimeters Standard Deviation 7.77	100.35 centimeters Standard Deviation 7.88
Change in Height (cm) Difference between T1 - T0	0.54 centimeters Standard Deviation 0.72	0.52 centimeters Standard Deviation 0.69
Change in Height (cm) Difference between T2 - T0	1.32 centimeters Standard Deviation 0.82	1.34 centimeters Standard Deviation 0.75
Change in Height (cm) Difference between T3 - T0	1.61 centimeters Standard Deviation 0.84	1.73 centimeters Standard Deviation 0.85

PRIMARY outcome

Timeframe: over 1 and 3 months

Population: Change of average weight for age Z Score and the difference between before intervention and after the intervention

Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=298 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Change of Height for Age Z-score Before intervention (T0)	-1.31 Z-score Standard Deviation 0.86	-1.24 Z-score Standard Deviation 0.94
Change of Height for Age Z-score After 1 month (T1)	-1.38 Z-score Standard Deviation 0.85	-1.32 Z-score Standard Deviation 0.93
Change of Height for Age Z-score After 2 months (T2)	-1.30 Z-score Standard Deviation 0.84	-1.24 Z-score Standard Deviation 0.93
Change of Height for Age Z-score After 3 months (T3)	-1.36 Z-score Standard Deviation 0.85	-1.27 Z-score Standard Deviation 0.94
Change of Height for Age Z-score Difference between T1 - T0	-0.07 Z-score Standard Deviation 0.18	-0.07 Z-score Standard Deviation 0.17
Change of Height for Age Z-score Difference between T2 - T0	0.01 Z-score Standard Deviation 0.19	0.00 Z-score Standard Deviation 0.19
Change of Height for Age Z-score Difference between T3 - T0	-0.05 Z-score Standard Deviation 0.20	-0.03 Z-score Standard Deviation 0.21

SECONDARY outcome

Timeframe: over 1 and 3 months

Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=293 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Changes in the Rate of Children Have Gastrointestinal Diseases Have diarrhea: During the first month of intervention (T1)	3 participants	11 participants
Changes in the Rate of Children Have Gastrointestinal Diseases Have diarrhea: During the second month of intervention (T2)	5 participants	3 participants
Changes in the Rate of Children Have Gastrointestinal Diseases Have diarrhea: During the third month of intervention (T3)	4 participants	1 participants
Changes in the Rate of Children Have Gastrointestinal Diseases Have constipation: During the first month of intervention (T1)	0 participants	0 participants
Changes in the Rate of Children Have Gastrointestinal Diseases Have constipation: During the second month of intervention (T2)	0 participants	0 participants
Changes in the Rate of Children Have Gastrointestinal Diseases Have constipation: During the third month of intervention (T3)	1 participants	0 participants

SECONDARY outcome

Timeframe: over 1 and 3 months

Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention

Outcome measures

Measure	Control Group n=299 Participants (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months	Specific Intervention Group n=293 Participants (n=300): Children eat the usual dietary and use 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends. Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of underweight : Before intervention (T0)	246 participants	244 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of underweight : After 1 month (T1)	240 participants	226 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of underweight : After 2 months (T2)	221 participants	207 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of underweight : After 3 months (T3)	220 participants	209 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of stunting : Before intervention (T0)	187 participants	205 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of stunting : After 1 month (T1)	196 participants	208 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of stunting : After 2 months (T2)	184 participants	206 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of wasting : After 2 months (T2)	148 participants	127 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of wasting : After 3 months (T3)	129 participants	118 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of stunting : After 3 months (T3)	191 participants	204 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of wasting : Before intervention (T0)	197 participants	187 participants
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting Malnutrition and risk of wasting : After 1 month (T1)	169 participants	146 participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Specific Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nguyen Song Tu

National Institute of Nutrient

Phone: 0912322602

Email: nguyensongtu@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place