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.
Full Title of Study: “Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators (Weight, Height), Nutrition Status, Digestive Disorders (Diarrhea, Constipation), and Anorexic in Children Between 24 – 71 Months Old.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 1, 2023
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.
- Dietary Supplement: 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.
Arms, Groups and Cohorts
- No Intervention: 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
- Experimental: 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.
Clinical Trial Outcome Measures
- Improvement of anthropometric indicators and nutrient status (wasting)
- Time Frame: Over 3 months of intervention
- Children in the intervention group will have more improvement with the anthropometric indicators (weight, height) than children in control group
- Improvement of digestive disorders and anorexia nervosa
- Time Frame: Over 3 months of intervention
- Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group
Participating in This Clinical Trial
- Children between the age of 24 – 71 months old that currently study in 10 preschools in the area of 10 selected communes. – The family volunteered for the child to participate in the study – Currently residing at 10 selected communes (over 1 year of residing) – Z-score WHZ/BAZ < – 0.5 Exclusion Criteria:
- Lactose intolerance – Children with a history of allergies, congenital diseases – Intellectual disability or are suffering from acute and chronic infectious diseases
Gender Eligibility: All
Minimum Age: 24 Months
Maximum Age: 71 Months
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Tu Nguyen Song
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Tu Nguyen Song, Head of Division Planning – National Institute of Nutrition, Vietnam
- Overall Official(s)
- Division of Planning National Institute of Nutrition, Principal Investigator, National Institute of Nutrition, Vietnam
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