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

NCT ID: NCT05670002

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-03-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Taking milk supplement

Group Type: OTHER

Milk supplement

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

FrieslandCampina

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Jan Jan Mohamed

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

School of Health Sciences

Kubang Kerian, Kelantan, Malaysia

Countries

Malaysia

Other Identifiers

Moana

Identifier Type: -

Identifier Source: org_study_id