Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT05670002
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
36 Months
Study:
NCT05670002
Study Brief:
Protocol Section:
NCT05670002