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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Open Label, Controlled Intervention Study to Investigate the Effects Oral Nutritional Supplement in Malaysian Children With Faltering Growth

Conditions
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Faltering Growth

Intervention / Treatment
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* Dietary Supplement: Milnutri Sure™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised, open label, controlled intervention study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The subjects in the treatment arm will be given Milnutri Sure TM product with dietary counselling | Dietary Supplement: Milnutri Sure™<br>* 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.<br>* Other names: oral nutritional support (ONS) product in powder format;|
| Active Comparator: Control<br>The subjects in the control arm, no Milnutri Sure TM product will be given, nevertheless, dietary counselling will be provided by the investigator. | Dietary Supplement: Milnutri Sure™<br>* 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.<br>* Other names: oral nutritional support (ONS) product in powder format;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight for Age (WAZ) score of the subject | derived from weight and age | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight for Height (WHZ) score, weight and height of the subject | derived from height and weight | 12 weeks | 
| (Serious) Adverse Events of the IP and possible relatedness to study | Number, type and severity of (Serious) Adverse Events and possible relatedness to study product | 12 weeks | 
| Percentage of compliance | Percentage of compliance via missed servings compared to expected servings on product intake | 12 weeks | 
| Appetite score | Appetite score according to a visual analogue scale (0-10) | 12 weeks | 
| Nutritional intake | Total energy intake and nutrient intake from solid food | 12 weeks |