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

Not Applicable

Completed

• Conditions: At Risk or Stunted Children
• Interventions: Dietary Supplement: Milk supplement

• Registration Number: NCT05670002
• Lead Sponsor: FrieslandCampina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-03
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Milk supplement	Taking milk supplement

Primary Outcome Measures

Name	Time	Method
Linear growth	6 months	Change in LAZ/HAZ z-score from baseline to after 6 months of intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Health Sciences; 🇲🇾 Kubang Kerian, Kelantan, Malaysia