Nutrition Intervention of Complementary Milk Feeding to I... | NCT05670002

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

NCT05670002

Sponsor

FrieslandCampina

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

118Actual

Phase

Not Applicable

Conditions

At Risk or Stunted Children

Interventions

Milk supplement

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2022Actual

Primary Completion Date

Mar 25, 2024Actual

Completion Date

Mar 25, 2024Actual

First Submitted Date

Dec 21, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Jan 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Name	Class
Universiti Sains Malaysia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Other	Taking milk supplement	Dietary Supplement: Milk supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hamid Jan Jan Mohamed	Universiti Sains Malaysia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
School of Health Sciences		Kubang Kerian	Kelantan		Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided