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NCT05670002
Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children
Conditions: At Risk or Stunted Children
Sex: All
Ages: 12 Months – 36 Months
Healthy volunteers: 1
Phase: NA
Enrollment: 110
Sponsor: FrieslandCampina
Location: Malaysia
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.
Eligibility Criteria
Inclusion Criteria:Malaysian childBoys and girls between the age of 12 and 36 monthsLength-for-age z score (LAZ) <-1.5 SD and > -3 SD according to the WHO Growth standardWeight-for-age z score WAZ <1.0 SD and > -3 SDParents and/or legal guardian who can speak and read Malay or English languageWritten informed consent from parents and/or legal guardianChild who are apparently healthy with no obvious on-going infection and no history of chronic illness.Child with no physical and/or mental illnessParents and/or legal guardian who owns a mobile phone or smart phoneMothers 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 40-64Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformityChild with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past monthChild with history of cow's milk allergy/intolerance to milkChild who is already taking multivitamins, including iron, before enrolled to the studyChild who is taking breastmilk as part of the diet
Source: ClinicalTrials.gov (NCT05670002). StuddyBuddy aggregates publicly available trial information.