At Risk or Stunted ChildrenNCT05670002
Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children
A study testing Milk supplement in people with At Risk or Stunted Children, run by FrieslandCampina at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- At Risk or Stunted Children
- What is being tested?
- Milk supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Nov 2022to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- At Risk or Stunted Children
- Being tested
- Milk supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Taking milk supplement Receives: Dietary Supplement: Milk supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth
Change in LAZ/HAZ z-score from baseline to after 6 months of intervention
Measured: 6 months
Secondary outcomes (2)
Growth velocity
Compare growth velocity between 3 months pre- to first 3 months and 6 months post intervention
Measured: 9 months
Zinc Protoporphyrin (ZnPP) levels
Any change in ZnPP levels pre and post intervention
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start30 Nov 2022
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At Risk or Stunted ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Sponsor
- Investigators
- Hamid Jan Jan Mohamed, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670002
- Sponsor's protocol ID
- Moana
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children Aged Between 12-36 Months
- ClinicalTrials.gov ID
- NCT05670002
- Acronym / sponsor ID
- Moana
- Conditions
- At Risk or Stunted Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Collaborators
- Universiti Sains Malaysia
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Dietary Supplement: Milk supplementTaking milk supplement |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk supplementChildren 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. | Dietary supplement | Intervention |
Primary outcome
Linear growth
Time frame: 6 months
Change in LAZ/HAZ z-score from baseline to after 6 months of intervention
2 secondary outcomes
Growth velocity
Time frame: 9 months
Zinc Protoporphyrin (ZnPP) levels
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Jan Jan Mohamed principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk supplement in people with At Risk or Stunted Children, run by FrieslandCampina at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear growth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.