Status:
UNKNOWN
Intervention Study to Investigate the Effects of ONS Use Among Malaysian Children With Faltering Growth
Lead Sponsor:
Danone Specialized Nutrition (M) Sdn Bhd
Collaborating Sponsors:
Universiti Putra Malaysia
Conditions:
Faltering Growth
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief 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 fr...
Detailed Description
Parent(s) of potentially eligible subjects will be informed about the study and what is expected in case of participation to the study. Information on the study is incorporated in the Respondent's Inf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05193630
Start Date
July 7 2022
End Date
August 30 2023
Last Update
August 25 2022
Active Locations (1)
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1
Hospital Pengajar Universiti Putra Malaysia
Serdang, Selangor, Malaysia, 43400