Despite the potential for improving iron status and child growth in low- and middle-income settings, concerns about the safety of high iron dosages of Micronutrient Powders (MNP currently limit their applicability in programs. Therefore, the main aim of this study was to assess the safety of iron supplementation in MNPs. For morbidity assessment of 65 eligible children per cluster (18 intervention and 18 non-intervention villages), a total of 2340 will be randomly selected.

Morbidity from infectious diseases will be assessed by means of a standardized recall questionnaire. Data will be collected on the following symptoms: diarrhea, respiratory signs, fever, and other illnesses. Children who require medical treatment will be examined by a Health Officer at the health center following standard protocols of the Federal Ministry of Health.

The biochemical iron status will be assessed from non-fasting venous morning blood samples. Blood samples will be kept cool, and serum separated and frozen at -20oC within 3 hours of collection. Hemoglobin, serum ferritin, C-reactive protein (CRP), soluble transferrin receptor, and AGP will be assessed following standardized methodologies at the laboratories of the Ethiopian Public Health Institute (EPHI).

Anthropometry: Trained field staff will collect duplicate measurements every four months of weight, recumbent length (infants), and height (children > 12 months) using standardized methods and high-quality equipment. Z-scores for length-for-age (LAZ), weight-for-age (WAZ), and weight-for-length (WLZ) will be calculated, using 2006 WHO Child Growth Standard; and stunting, under-weight, and wasting will be defined as LAZ, WAZ, and LAZ <-2 SD, respectively.

Infant feeding status. Information on infant feeding status will be collected every four months by means of a standardized questionnaire. Compliance with the program intervention: will be assessed by counting the number of returned and used MNP sachets every 2 weeks. Social, economic, and demographic characteristics: will be collected in baseline questionnaires using Demographic and Health Survey methods.

• Iron
• Low dose
• Micronutrient powder
• Morbidity
• Young children
• Program evaluation
• Process and impact evaluation
• Micronutrient powder (MNP) safety
• Micronutrients
• Trace Elements
• Physiological Effects of Drugs

Not mentioned by the data generating unit.

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 a standardized questionnaire will be collected at baseline and every two weeks for a period of 12 months. Based on this, this research tried to answer the following research questions: 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. 3. Body iron status will be assessed at baseline and end-line as measured by serum ferritin, serum transferrin receptor, hemoglobin concentration, CRP, and AGP.

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