Undernutrition Clinical Trial
Official title:
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.
Verified date | September 2022 |
Source | National Institute of Nutrition, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | August 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Months to 71 Months |
Eligibility | Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Yen Bai Province Obstetrics and Children's Hospital | Yen Bai |
Lead Sponsor | Collaborator |
---|---|
Tu Nguyen Song |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in the risk of wasting and malnutrition | Changes in the risk of wasting and malnutrition after 1, 2 and 3 months of intervention | over 1 and 3 months | |
Other | The change in the rate of wasting and malnutrition | The change in the rate of wasting and malnutrition after 1, 2, and 3 months of intervention | over 1 and 3 months | |
Primary | Improvement of anthropometric indicators and nutrient status (wasting) | Children in the intervention group will have more improvement with the anthropometric indicators (weight, height) than children in control group | Up to 3 months of intervention | |
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 | From date of using the product until the date of first documented improvement, assessed up to 3 months | |
Secondary | Body Mass Index, i.e. changes of Body Mass Index (BMI) | 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 center of the scale. As soon as the balance is stable, read and write the result in kg and an odd number after the comma.
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) |
over 1 and 3 months | |
Secondary | Change of weight for age Z-score | Change of average weight for age Z Score and the difference between before intervention and after the intervention | over 1 and 3 months | |
Secondary | Change of weight for height Z-score | Change of average weight for height Z Score and the difference between before intervention and after the intervention | over 1 and 3 months | |
Secondary | Change of height for age Z-score | Change of average height for age Z Score and the difference between before intervention and after the intervention | over 1 and 3 months | |
Secondary | Changes in the rate of children have anorexia or gastrointestinal diseases | Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation), and anorexia above after intervention | over 1 and 3 months |
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