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

Study Overview
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Brief Summary
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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.

Official Title
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Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children Aged Between 12-36 Months

Conditions
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At Risk or Stunted Children

Intervention / Treatment
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* Dietary Supplement: Milk supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Taking milk supplement | Dietary Supplement: Milk supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 9 months |