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Practice of Nutrition Package in Myanmar

NCT06827964 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Malnutrition in Children

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).

Sponsors & Collaborators

  • Tsinghua University

    lead OTHER

Principal Investigators

  • Ai Zhao · Vanke School of Public Health, Tsinghua University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-09-10
Completion
2025-09-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827964 on ClinicalTrials.gov