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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Faltering Growth
• Intervention / Treatment: Dietary supplement: Milnutri Sure™

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.

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zurina Zainudin; Phone Number: +6012-2642174; Email: zaizurina@upm.edu.my
• Study Contact Backup: Name: Diana Rashid; Phone Number: +6013-4619940; Email: diana.rashid@questra.com.my

Study Locations

• Malaysia
  • Selangor Darul Ehsan
    • Serdang, Selangor Darul Ehsan, Malaysia, 43400
      • Recruiting
      • Hospital Pengajar Universiti Putra Malaysia
      • Contact: ZURINA ZAINUDDIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; The subjects in the treatment arm will be given Milnutri Sure TM product with dietary counselling	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.; Other Names: oral nutritional support (ONS) product in powder format
ACTIVE_COMPARATOR: Control; 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™; 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.; Other Names: oral nutritional support (ONS) product in powder format

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sick days	Number of sick days assessed via the investigator, who, at each clinic visit, asks the parents for the number of sick days during the past 4 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: Danone Specialized Nutrition (M) Sdn Bhd
• Collaborators: Universiti Putra Malaysia
• Investigators: Principal Investigator: Zurina Zainudin, Universiti Putra Malaysia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): August 30, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (ACTUAL): January 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Failure to Thrive
• Other Study ID Numbers: FS21-MONS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No