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Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia

NCT02479815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2356

Last updated 2018-01-31

No results posted yet for this study

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.

Conditions

  • Nutritional Anemia
  • Infant Morbidity

Interventions

DIETARY_SUPPLEMENT

Micronutrient Powder (MNP)

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.

Sponsors & Collaborators

  • Ethiopian Public Health Institute

    lead OTHER_GOV

  • Micronutrient Initiative

    collaborator OTHER

  • Wageningen University

    collaborator OTHER

Principal Investigators

  • Saskia JM Osendarp, PhD · Micronutrient Initiative

  • Inge D Brouwer, PhD · Wageningen University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-05-31
Completion
2016-08-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02479815 on ClinicalTrials.gov