NCT05193630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

January 3, 2022

Last Update Submit

August 22, 2022

Conditions

Faltering Growth

Outcome Measures

Primary Outcomes (1)

  • Weight for Age (WAZ) score of the subject

    derived from weight and age

    12 weeks

Secondary Outcomes (5)

  • Weight for Height (WHZ) score, weight and height of the subject

    12 weeks

  • (Serious) Adverse Events of the IP and possible relatedness to study

    12 weeks

  • Percentage of compliance

    12 weeks

  • Appetite score

    12 weeks

  • Nutritional intake

    12 weeks

Other Outcomes (1)

  • Number of sick days

    12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

The subjects in the treatment arm will be given Milnutri Sure TM product with dietary counselling

Dietary Supplement: Milnutri Sure™

Control

ACTIVE COMPARATOR

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™

Interventions

Milnutri Sure™DIETARY_SUPPLEMENT

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.

Also known as: oral nutritional support (ONS) product in powder format
ControlTreatment

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pengajar Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

Failure to Thrive

Interventions

Nutritional SupportPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Zurina Zainudin

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zurina Zainudin

CONTACT

+6012-2642174zaizurina@upm.edu.my

Diana Rashid

CONTACT

+6013-4619940diana.rashid@questra.com.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The anthropometric outcomes will be blinded to assessors and analyst until at least the primary outcomes have been analysed to reduce bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised, open label, controlled intervention study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 18, 2022

Study Start

July 7, 2022

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)