Clinical trial NCT05193630: Intervention Study to Investigate the Effects of ONS Use Among Malaysian Children With Faltering Growth
Official title: A Randomised, Open Label, Controlled Intervention Study to Investigate the Effects Oral Nutritional Supplement in Malaysian Children With Faltering Growth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Faltering Growth
Lead sponsor: Danone Specialized Nutrition (M) Sdn Bhd
Sponsor class: INDUSTRY
Collaborators: name: Universiti Putra Malaysia
First posted: 2022-01-18
Enrollment: 172
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, open label, controlled intervention study
Primary purpose: TREATMENT

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 from ≥ 1 to ≤ 6 years of age with faltering growth for duration of 12 weeks.

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 Information Sheet (RIS). The parent(s) will be given sufficient time to read and understand the Information Sheet and to ask questions. Parent(s) of eligible subjects will be approached at the main study clinic or they may be referred from one of the 'satellite clinics'. In case of referral, they will be pre-screened at the satellite clinic and if considered potentially eligible for the MONS study, they will be referred to the main study clinic for full screening.

If subjects fulfil all inclusion and exclusion criteria, and if the parent(s) is (are) willing that his/her/their child will participate, he/she/they will be asked to sign the Informed Consent Form (ICF). Baseline evaluation (including history and anthropometric measurement) will be completed prior to randomisation. A block randomisation will be performed to allocate subjects to treatment arm or control arm in 1:1 ratio.

At enrolment, the investigator assesses baseline characteristics, anthropometrics, appetite score, and the number of the child's sick days during the 4 weeks before enrolment. At the end of the visit, the investigator will provide two 3-days feeding diaries (one for baseline and one for Visit 2) and explain how and when these should be completed. The investigator will provide the Milnutri Sure™ product to the parent whose child is in the treatment arm, explain how to use the Milnutri Sure™ and how to apply other feeding advices for the coming 4 weeks until the next visit. For parent whose child is in the control arm, no Milnutri Sure TM product will be given, nevertheless, dietary counselling will be provided by the investigator.

Four, eight and twelve weeks after enrolment, subjects will have clinic visits (Visit 2, 3 and 4) and the anthropometrics, adverse events, appetite score, compliance, and the number of the children's sick days since last visit will be assessed. At the end of the visit the investigator will provide the product to the parents whose children are in the treatment arm, explains how to use it and how to apply other feeding advices for the coming 4 weeks until the next visit. For parents whose children are in the control arm, though no Milnutri Sure TM product will be given, dietary counselling will be provided by the investigator. At week eight (Visit 3), the investigator will also provide a 3-days feeding diary to the parents to be completed just before the twelve-week 12 visit (Visit 4).

In addition to this, at Visit 4 (the End of Study visit after 12 weeks in the study) the investigator will fill out the end of study visit requirements and stops providing study product. The investigator may request for a follow-up visit to monitor and provide medical and dietary counselling to the subject. If necessary, the investigator may prescribe Milnutri Sure ™ or any other growing up milk or nutritional counselling as part of normal practice.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Weight for Age (WAZ) score of the subject
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight for Height (WHZ) score, weight and height of the subject
timeFrame: 12 weeks
measure: (Serious) Adverse Events of the IP and possible relatedness to study
timeFrame: 12 weeks
measure: Percentage of compliance
timeFrame: 12 weeks
measure: Appetite score
timeFrame: 12 weeks
measure: Nutritional intake
timeFrame: 12 weeks
Other outcomes:
measure: Number of sick days
timeFrame: 12 weeks
Locations:
city: Serdang
country: Malaysia
facility: Hospital Pengajar Universiti Putra Malaysia
state: Selangor Darul Ehsan
Study officials:
affiliation: Universiti Putra Malaysia
name: Zurina Zainudin
role: PRINCIPAL_INVESTIGATOR
References: