Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of At Risk and Stunted Children

Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of At Risk and Stunted Children Aged Between 12-36 Months

This is a non-randomized open label 6 months intervention study that aims to assess the effectiveness of consuming milk daily for 6 months will improve the linear growth rate of children aged 12-36 months.

Study Overview

• Status: Completed
• Conditions: At Risk or Stunted Children
• Intervention / Treatment: Dietary supplement: Milk supplement

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia
      • School of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Malaysian child
2. Boys and girls between the age of 12 and 36 months
3. Length-for-age z score (LAZ) <-1.5 SD and > -3 SD according to the WHO Growth standard
4. Weight-for-age z score WAZ <1.0 SD and > -3 SD
5. Parents and/or legal guardian who can speak and read Malay or English language
6. Written informed consent from parents and/or legal guardian
7. Child who are apparently healthy with no obvious on-going infection and no history of chronic illness.
8. Child with no physical and/or mental illness
9. Parents and/or legal guardian who owns a mobile phone or smart phone
10. Mothers who have ever received breastfeeding counselling from a qualified breastfeeding counsellor.

Exclusion Criteria:

1. Child with zinc protoporphyrin (ZnPP) value of >65 (at either -T3 or T0)
2. Clinical symptoms of iron deficiency as examined by Doctor even with zinc protoporphyrin (ZnPP) value between 40-64
3. Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformity
4. Child with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past month
5. Child with history of cow's milk allergy/intolerance to milk
6. Child who is already taking multivitamins, including iron, before enrolled to the study
7. Child who is taking breastmilk as part of the diet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Taking milk supplement	Dietary supplement: Milk supplement; Children will take the milk supplement for a period of 6 months. During the intervention, anthropometry data, Zinc Protoporphyrin levels, dietary intake, any illness will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear growth	Change in LAZ/HAZ z-score from baseline to after 6 months of intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth velocity	Compare growth velocity between 3 months pre- to first 3 months and 6 months post intervention	9 months
Zinc Protoporphyrin (ZnPP) levels	Any change in ZnPP levels pre and post intervention	9 months

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Collaborators: Universiti Sains Malaysia
• Investigators: Principal Investigator: Hamid Jan Jan Mohamed, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Moana

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
• product manufactured in and exported from the U.S.: No