Practice of Nutrition Package in Myanmar

ConditionMalnutrition in Children

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-15

SponsorTsinghua University

About this trial

The goal of this cluster randomized controlled trial is to study the effectiveness of the Nutrition Package (Yingyangbao) on improving malnutrition in children and adolescents aged 7-15 in Myanmar. The main questions it aims to answer are:

* What is the effectiveness of Nutrition Package intervention on the growth, development, and nutritional health of children and adolescents aged 7-15 in Myanmar? * How safe and feasible is the Nutrition package? Researchers will compare the Nutrition Package plus probiotics, the Nutrition Package alone, and no intervention to see if the Nutrition Package improves malnutrition and other health outcomes of children and adolescents aged 7-15 in Myanmar.

Participants will receive Nutrition Package products for six months and have their height, weight, mid-upper arm circumference, and hemoglobin levels measured and compared at baseline and end.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children and adolescents aged 7-15 years.

Residing in the local area for more than 1 year.

Disqualifiers

Individuals with severe metabolic diseases.

Diagnosed with HIV/AIDS.

Individuals with physical disabilities.

Individuals with severe mental conditions that may hinder their ability to cooperate with the study.

Trial design

Design model

Parallel

Treatments tested in this trial

Soy-based Nutrition Package
Dietary supplement
Dry, vacuum-sealed sachets containing yellow powder, odorless, to be consumed with warm water. Each 12g sachet provides: 209 kJ energy, 3.1g protein, 1.7g fat, 4.6g carbohydrates, 3mg sodium, 200mg calcium, 7.5mg iron, 3mg zinc, 250μg RE vitamin A, 5μg vitamin D, 0.5mg vitamin B1, 0.5mg vitamin B2, 0.5μg vitamin B12, and 75μg folate. Intervention duration: 6 months, with 2 sachets per day. Produced by Tiantianai (Jiangsu) Biotechnology Co., Ltd., a certified supplier for maternal and child nutrition projects in China.The company has a Class D production workshop that meets the latest GMP standards for pharmaceuticals. The product has passed certifications for Food Safety Management System (ISO 22000) and Quality Management System (ISO 9001).
Probiotics
Dietary supplement
Dry, vacuum-sealed sachets containing white powder, odorless. Each 2g sachet contains 500\*10\^9 CFU of Lactobacillus plantarum LLY-606 and Pediococcus pentosaceus JQI-7. Intervention duration: 6 months, with 1 sachet per day. Produced by Jiangsu Wecare Biotechnology Co., Ltd., compliant with international standards (cGMP, FSSC 22000, HACCP, ISO 22000, ISO 9001).

Treatment groups

600 Participants

are divided into 3 treatment groups

Group A: Group 1Experimental treatment 2 interventions

Group B: Group 2Experimental treatment 1 intervention

Group C: Group 3No intervention 0 interventions

Trial outcomes

Primary outcomes

Physical examination

Height and weight are measured using a height and weight meter, and mid-upper arm circumference is measured using an arm circumference ruler.

Time frame

At the enrollment, later 3 month and later 6 month.

Secondary outcomes

Hemoglobin determination

Hemoglobin of finger-tip blood is measured using a HemoCue hemoglobin analyzer.

Time frame

At the enrollment, later 3 month and later 6 month.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tsinghua University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: