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NOT YET RECRUITING
NCT06827964
NA

Practice of Nutrition Package in Myanmar

Sponsor: Tsinghua University

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Nutrition Package (Yingyangbao) Intervention on Children and Adolescents' Health in Myanmar

Key Details

Gender

All

Age Range

7 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-03-10

Completion Date

2025-09-10

Last Updated

2025-02-20

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Soy-based Nutrition Package

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).

DIETARY_SUPPLEMENT

Probiotics

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).