At Risk or Stunted Children
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMilk 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.
Sponsors
Universiti Sains Malaysia
FrieslandCampina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear growth | 6 months | Change in LAZ/HAZ z-score from baseline to after 6 months of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth velocity | 9 months | Compare growth velocity between 3 months pre- to first 3 months and 6 months post intervention |
| Zinc Protoporphyrin (ZnPP) levels | 9 months | Any change in ZnPP levels pre and post intervention |
Countries
Malaysia
Outcome results
None listed