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
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 Antena...
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08024-w |
| _version_ | 1797266607222816768 |
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| author | Desalegn Kuche Zeweter Abebe Masresha Tessema Meron Girma Alemayehu Hussen Kaleab Baye Barbara J. Stoecker |
| author_facet | Desalegn Kuche Zeweter Abebe Masresha Tessema Meron Girma Alemayehu Hussen Kaleab Baye Barbara J. Stoecker |
| author_sort | Desalegn Kuche |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-25T01:03:23Z |
| format | Article |
| id | doaj.art-00dd8257c08e44dc8324577e47a50aaf |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-25T01:03:23Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-00dd8257c08e44dc8324577e47a50aaf2024-03-10T12:21:31ZengBMCTrials1745-62152024-03-0125111410.1186/s13063-024-08024-wThe 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 RCTDesalegn Kuche0Zeweter Abebe1Masresha Tessema2Meron Girma3Alemayehu Hussen4Kaleab Baye5Barbara J. Stoecker6Ethiopian Public Health InstituteAddis Ababa UniversityEthiopian Public Health InstituteEthiopian Public Health InstituteEthiopian Public Health InstituteAddis Ababa UniversityOklahoma State UniversityAbstract 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.https://doi.org/10.1186/s13063-024-08024-wUNIMMAP-MMSIFAAnemiaTrialWomen of reproductive age |
| spellingShingle | Desalegn Kuche Zeweter Abebe Masresha Tessema Meron Girma Alemayehu Hussen Kaleab Baye Barbara J. Stoecker 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 Trials UNIMMAP-MMS IFA Anemia Trial Women of reproductive age |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | UNIMMAP-MMS IFA Anemia Trial Women of reproductive age |
| url | https://doi.org/10.1186/s13063-024-08024-w |
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