Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia
Condition: Nutritional Anemia; Infant Morbidity
Study type: Interventional

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.
    

Detailed description: 
      For morbidity assessment 65 eligible children per cluster (18 intervention and
      18non-intervention villages) a total of 2340 will be randomly selected The sample size was
      calculated based on an expected 12% increase in the incidence of overall diarrhoea and 30%
      decrease in anemia in the intervention group. The investigators assume that the investigators
      will be able to detect this increase with 80% power and 95% confidence interval, with an
      assumed 10% drop-out and design effect of two.

        -  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.

        -  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 the 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 to 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.

      Data will be analysed on an intention-to-treat basis, using the SPSS 19.0 statistical
      program. Random effect models will be used to account for repeated measures or episodes
      within children, and multiple children in each cluster.

      For morbidity, the number of actual surveillance days will be counted by subtracting the days
      on which no recall data were available from the total days of follow-up. For the analysis of
      disease incidence, differences between groups will be assessed with random effects regression
      including number of episodes as dependent, control- or intervention as independent, and total
      days of actual surveillance as off-set term in the model. Longitudinal prevalence of disease
      will be calculated for each individual as the percentage of actual surveillance days with
      illness. All continuous variables (longitudinal prevalence, body iron status, mean and total
      weight and height gain) will be analysed using linear mixed models using cluster, household
      and child as random effects to account for clustered observations. Mixed effects logistic
      regression analysis will be used to evaluate binary outcomes (anemia, iron deficiency and
      iron-deficiency anemia), using cluster, household and child as random effects. All models
      will include the following fixed effects as co-variates: child's sex, socio-economic status,
      and baseline values. Non-normal distributed values will be log-transformed. P-values of <
      0.05 will be considered statistically significant.
    

Intervention name(s): Micronutrient Powder (MNP)
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention MeSH terms: Micronutrients; Trace Elements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Complementary feeding recommendation; Program evaluation; Process and impact evaluation; Micronutrient powder (MNP) safety