UnknownNot Applicable

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

Malaysia172 participantsStarted 2022-07-07

Plain-language 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.

Who can participate

Age range1 Year – 6 Years

SexALL

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Inclusion criteria

✓. Age: ≥1 and ≤ 6 years of age.
✓. Weight at baseline between ≥ -3 and \< -1 SD WHO-score (mild to moderate undernutrition).
✓. Informed consent provided.

Exclusion criteria

✕. Underlying medical illness affecting growth, according to the clinician's opinion
✕. Known lactose intolerance / cow's milk allergy
✕. Use of (other) ONS 1+ (1 kcal/mL) at enrolment and/or during the three months before enrolment
✕. Other family member is already participating in this MONS study.
✕. Insufficient ability to understand or communicate in English and/or Bahasa Malaysia
✕. Participating in any other clinical study

What they're measuring

Weight for Age (WAZ) score of the subject

Timeframe: 12 weeks

Trial details

NCT IDNCT05193630

SponsorDanone Specialized Nutrition (M) Sdn Bhd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Zurina Zainudin

+6012-2642174 zaizurina@upm.edu.my

View on ClinicalTrials.gov More Faltering Growth trials