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

NCT05670002 | Completed

• 1 other identifier: Moana
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

At Risk or Stunted Children

Outcome Measures

Primary Outcomes (1)

• Linear growth

  Change in LAZ/HAZ z-score from baseline to after 6 months of intervention

  6 months

Secondary Outcomes (2)

• Growth velocity

  9 months

• Zinc Protoporphyrin (ZnPP) levels

  9 months

Study Arms (1)

Intervention

OTHER

Taking milk supplement

Dietary Supplement: Milk supplement

Interventions

Milk supplement DIETARY_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.

Intervention

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• FrieslandCampina: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

School of Health Sciences

Kubang Kerian, Kelantan, Malaysia

Location

Study Officials

• Hamid Jan Jan Mohamed

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 3, 2023
• Study Start: November 30, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)