At a glance
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Assessing the Safety of Iron Supplementation in Micronutrient Powder (MNPs)
In Brief
A clinical study evaluating Micronutrient Powder (MNP) for Nutritional Anemia and Infant Morbidity. Completed, enrolled 2,356 participants across 1 site.
Detailed Summary
The purpose of the study is to assess the safety of iron supplementation in MNPs. A quasi-experimental matched-control cluster design will be used in, purposely selected, 18 intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from intervention and non-intervention clusters will be enrolled and followed longitudinally for 12 months. Morbidity data using standardized questionnaire, will be collected at baseline, and every two weeks for a period of 12 months Research questions to be answered in this study are: 1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children with or without iron deficiency safe, as assessed by their morbidity from infectious diseases? 2. What is the impact of the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children on (body) iron status? Morbidity data will be collected at baseline, and every two weeks in the same cohort of children. Body iron status will be assessed at baseline and endline as measured by serum ferritin, serum transferrin receptor, hemoglobin concentration, CRP and AGP. In addition data on the following outcomes will be collected in these children: 1. Anthropometry (weight, height, MUAC) every 4 months 2. Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months 3. Compliance to study intervention.
Study Details
Timeline
Interventions
Every month, 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day. The MNPs sachets will contain 6 mg Fe together with 14 other vitamins and minerals.