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Intervention Study to Investigate the Effects of ONS Use Among Malaysian Children With Faltering Growth

NCT05193630 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2022-08-25

No results posted yet for this study

Summary

A randomised, open label, controlled intervention study to test the effect of the test product with dietary counselling versus dietary counselling alone on Weight-for-Age z-score change in children from ≥ 1 to ≤ 6 years of age with faltering growth for duration of 12 weeks.

Conditions

  • Faltering Growth

Interventions

DIETARY_SUPPLEMENT

Milnutri Sure™

Milnutri Sure™, a commercially available oral nutritional support (ONS) product in powder format, for children of 1 y of age and above (1.0 kcal /ml). For children between 1 and 3 years of age, the recommendation is to use 2 servings per day, and for children from 4 to 6 years of age, the recommendation is to give 3 servings per day. One serving contains of 45 grams of product and 180 ml water.

Sponsors & Collaborators

  • Universiti Putra Malaysia

    collaborator OTHER

  • Danone Specialized Nutrition (M) Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Zurina Zainudin · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-06-30
Completion
2023-08-30

Countries

  • Malaysia

Study Locations

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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 NCT05193630 on ClinicalTrials.gov