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Evaluating the efficiency of using Oral Nutritional Supplementation toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24 - 71 months.
Evaluating the efficiency of using Oral Nutritional Supplementation toward the improvement of the anthropometric index (weight, height, weight for age Z-score, height for age Z-score, and weight for height Z-score ), nutrition status (the prevalence of wasting) in children aged 24 - 71 months after 3 months using the nutrient product.
Evaluating the efficiency of using Oral Nutritional Supplementation for digestive disorders and anorexic in children aged 24 - 71 months.
The research involves a randomized controlled clinical trial (RCT). The plan is expected to conduct from 2022 to 2023 with over 600 children aged 24-71 months. The nutrient product produces a high amount of energy that provides over 472kcal/100g; 15,6g/100g of protein; 20,8g/100 of fat; 55,6g/100g of carbonhydrate; 338mg/100g of alpha-Linolenic acid; 1800mg/100g of Linoleic acid; 19,7mg/100g of 2'FL HMO; 1088mg/100g of MCT; 2700mg/100g of FOS/Inulin; 55mg/100g of GOS; 1000mg/100g of Lysine; 687mg/100g of Calcium; 68mg/100g of Magnesium; 6,5mg/100g of Iron; 3,6/100g of Zinc; 41,9µg/100g of Manganese; 2176IU/100g of Vitamin A; 376 IU/100g of Vitamin D3; 44µg/100g of Vitamin K1; 820µg/100g of Vitamin B1; 900µg/100g of Vitamin B2; 610µg/100g of Vitamin B6; 1,92µg/100g Vitamin B12; 4140µg/100g of Acid Pantothenic; 115µg/100g of Acid Folic; 98,2 grams of the product, which equals 2 packs (230ml x 2 per day) will supply about 36,4% - 48,1% of the required energy for children aged 2-5 years old. Additional components include Alpha-Linolenic Acid, which provides 67% of the recommended dietary allowances (RDAs), Linolenic Acid 60, which provides 90% RDAs, and 25 other micronutrients and minerals that include some essential vitamins such as Calcium 112-114% RDAs, Iron 118-120.4% RDAs, Vitamin A 145-174% RDAs, Zinc 75-87% RDAs, Vitamin D3 62% RDAs, Seleni 53-63% RDAs, Vitamin K 63-73% RDAs, Folic Acid 76-115% RDAs. With other elements such as 2'FL HMO (19,7 mg), FOS/inulin (2700 mg), Choline ( 47 mg, Taurine 20 mg) , multi medium-chain triglyceride (MCT) (1088 mg), Bifidobacterium longum (109 CFU). The study will be conducted at schools and homes: 600 children erratically divided into 2 groups, 1 group will use the product for 3 months ( with the amount of use: twice per day, 49,2 grams each time). The product will be distributed to the students through the schools. Monitoring will be performed carefully by the commune and district Health Department and the Centers for Disease Control and Prevention weekly. The study aims to evaluate the efficiency of nutrient products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24-71 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | (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 | Experimental | (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kazu Gain Gold | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Digestive Disorders and Anorexia Nervosa | Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group | From date of using the product until the date of first documented improvement, assessed up to 3 months |
| Change in Weight (kg) | 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) | over 1 and 3 months |
| Change of Weight for Age Z-score | 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. | over 1 and 3 months |
| Change of Weight for Height Z-score | 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. | over 1 and 3 months |
| Change in Height (cm) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Rate of Children Have Gastrointestinal Diseases | Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention | over 1 and 3 months |
| Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Division of Planning National Institute of Nutrition | National Institute of Nutrition, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yen Bai Province Obstetrics and Children's Hospital | Yên Bái | 33000 | Vietnam |
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| Label | URL |
|---|---|
| Click here for more information about the organization in which this study is conducted. The Division of Planning is responsible to plan and implement the project. | View source |
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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.
Location: Yen Bai Provincial Children's Hospital
Recruitment time: August 1st, 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Specific Intervention Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement of Digestive Disorders and Anorexia Nervosa | Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group | Posted | Number | participants | From date of using the product until the date of first documented improvement, assessed up to 3 months |
|
At school, the intervention product would passed to teachers (on weekdays) and parents (at weekends). The oral product should be used every day based on the instructions. Observe the participants every day and note down any situation that occurred in the designed notebook. This will continue every day for three months.
Adverse events were recorded along with health status, product usage, abnormal symptoms, and daily health conditions in a monitoring log maintained by parents and teachers under the supervision of healthcare staff and community health officers at the district level.
Collaborators are responsible for advising research subjects or requesting to go to a medical facility when experiencing nausea, diarrhea or other unusual symptoms
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Due to research ethics, the intervention and control groups consume the products. Moreover, some children might drink other supplements or products that improve their weight and height at home. However, it does not strongly affect the result of this research
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nguyen Song Tu | National Institute of Nutrient | 0912322602 | nguyensongtu@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2023 | Nov 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D002100 | Cachexia |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
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Step 1: Investigate the nutrition status of all children aged 24 - 71 months in 10 preschools in 10 selected communes. Expecting 3500 targets in 10 examined preschools
Step 2: After the investigative selection, participants that meet the standard will be invited to the study ( the communes selected can be narrowed if the targets are hit). As soon as parents sign the consent paper, the study will move to the next step.
Step 3: Groups will be divided to investigate activities. Creating a list for all participants that meet the criteria, with WHZ/BAZ <-0,5. Randomly selection based on age to ensure that there is no significant difference in the nutritional index or related indicators in the group to assess the effectiveness of the intervention (divided by class/age). Then, randomly divided the target by class into three large groups (300 targets per group)
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Control Group (311 participants): Children eat their usual dietary(not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product for 3 months.
Specific Intervention Group (311 participants): Children eat the usual dietary, with 2 glasses of Oral Nutritional Supplementation as the side meal. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.
|
| over 1 and 3 months |
| Change of Height for Age Z-score | 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. | 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 |
| over 1 and 3 months |
(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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Anthropometric characteristics of the subjects at the time of initial investigation | Mean | Standard Deviation | Z-score |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Months of age | Mean | Standard Deviation | months |
|
|
|
| Primary | Change in Weight (kg) | 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) | 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. | Posted | Mean | Standard Deviation | kilograms | over 1 and 3 months |
|
|
|
| Primary | Change of Weight for Age Z-score | 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. | 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. | Posted | Median | Standard Deviation | Z-score | over 1 and 3 months |
|
|
|
| Primary | Change of Weight for Height Z-score | 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. | Change of average weight for height Z Score and the difference between before intervention and after the intervention | Posted | Median | Standard Deviation | Z-score | over 1 and 3 months |
|
|
|
| Primary | Change in Height (cm) | 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) | 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. | Posted | Mean | Standard Deviation | centimeters | over 1 and 3 months |
|
|
|
| Primary | Change of Height for Age Z-score | 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. | Change of average weight for age Z Score and the difference between before intervention and after the intervention | Posted | Median | Standard Deviation | Z-score | over 1 and 3 months |
|
|
|
| Secondary | Changes in the Rate of Children Have Gastrointestinal Diseases | Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention | Posted | Number | participants | over 1 and 3 months |
|
|
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| Secondary | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention | Posted | Number | participants | over 1 and 3 months |
|
|
|
| 0 |
| 299 |
| 0 |
| 299 |
| 0 |
| 299 |
| EG001 | 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. | 0 | 293 | 0 | 293 | 0 | 293 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D012817 | Signs and Symptoms, Digestive |
| After 2 months (T2) |
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| After 3 months (T3) |
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| Difference between T1 - T0 |
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| Difference between T2 - T0 |
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| Difference between T3 - T0 |
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| After 2 months (T2) |
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| After 3 months (T3) |
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| Difference between T1 - T0 |
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| Difference between T2 - T0 |
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| Difference between T3 - T0 |
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| After 2 months (T2) |
|
| After 3 months (T3) |
|
| Difference between T1 - T0 |
|
| Difference between T2 - T0 |
|
| Difference between T3 - T0 |
|
| After 2 months (T2) |
|
| After 3 months (T3) |
|
| Difference between T1 - T0 |
|
| Difference between T2 - T0 |
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| Difference between T3 - T0 |
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| After 2 months (T2) |
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| After 3 months (T3) |
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| Difference between T1 - T0 |
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| Difference between T2 - T0 |
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| Difference between T3 - T0 |
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| Have diarrhea: During the third month of intervention (T3) |
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| Have constipation: During the first month of intervention (T1) |
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| Have constipation: During the second month of intervention (T2) |
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| Have constipation: During the third month of intervention (T3) |
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| Malnutrition and risk of underweight : After 2 months (T2) |
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| Malnutrition and risk of underweight : After 3 months (T3) |
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| Malnutrition and risk of stunting : Before intervention (T0) |
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| Malnutrition and risk of stunting : After 1 month (T1) |
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| Malnutrition and risk of stunting : After 2 months (T2) |
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| Malnutrition and risk of stunting : After 3 months (T3) |
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| Malnutrition and risk of wasting : Before intervention (T0) |
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| Malnutrition and risk of wasting : After 1 month (T1) |
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| Malnutrition and risk of wasting : After 2 months (T2) |
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| Malnutrition and risk of wasting : After 3 months (T3) |
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