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. 2024 Mar 6;25(1):170.
doi: 10.1186/s13063-024-08024-w.

The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT

Desalegn Kuche  1   2   3 , Zeweter Abebe  4 , Masresha Tessema  5 , Meron Girma  5 , Alemayehu Hussen  5 , Kaleab Baye  4 , Barbara J Stoecker  6
Affiliations

The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT

Desalegn Kuche et al. Trials. .

Abstract

Background: Women of reproductive age (WRA) in developing countries are often at risk of micronutrient deficiencies due to inadequate intakes and excessive losses.

Objective: The purpose of this trial is to assess the effectiveness of United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) versus iron-folic acid (IFA) among WRA in reducing anemia.

Methods: Three parallel groups of WRA will participate in a community-based, individually randomized, double-blinded, placebo-controlled superiority trial. After consent, the sample of 375 mildly or moderately anemic women based on hemoglobin by Hemocue will be randomly assigned across two interventions and one control arm. Trial participants in intervention arms will receive UNIMMAP-MMS or IFA while those in the control arm will receive placebos twice a week for 17 weeks. The primary outcome will be a change in mean hemoglobin (Hb) concentrations. Outcome assessors and study participants will be blinded to the type of supplements and study arm.

Discussion: The World Health Organization (WHO) added UNIMMAP-MMS to its essential medicine lists in 2021 but recommended rigorous study. Several factors in addition to inadequate intakes of iron and folic acid contribute to the high prevalence of anemia among WRA in the Somali region. The findings of this study will provide evidence on the effect of UNIMMAP-MMS and IFA on Hb concentrations and anemia prevalence among anemic WRA.

Trial registration: ClinicalTrials.gov NCT05682261. Registered on January 12, 2023.

Keywords: Anemia; IFA; Trial; UNIMMAP-MMS; Women of reproductive age.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Maps of the study areas illustrating the study region (A), zone (B), and woreda (C). A Ethiopia is divided into regional states, and the Somali Regional State is one of the 12 regional states in Ethiopia. B Regional states are divided into zones. Fafan Zone is one of the zones in the Somali Regional State. C Zones are divided into woredas (districts), and woredas are divided into kebeles, the last administrative divisions. The four study kebeles included in the study are in Kebribeyah Woreda
Fig. 2
Fig. 2
A flow diagram illustrating the study sites and their selection criteria. SRS, simple random sampling; TSFP, Targeted Supplementary Feeding Program, EAs, Enumeration Areas
Fig. 3
Fig. 3
A flow diagram illustrating the recruitment and allocation of participants in the study. n, number of study participants planned; IFA, iron-folic acid; UNIMMAP-MMS, United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements
Fig. 4
Fig. 4
Schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

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