Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607744914189 Date of Registration: 17/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of multiple micronutrient supplements versus iron-folic acid interventions for pregnant women to improve maternal hemoglobin in Ethiopia
Official scientific title Effectiveness of multiple micronutrient supplements versus iron-folic acid interventions for pregnant women to improve maternal hemoglobin in Ethiopia
Brief summary describing the background and objectives of the trial Multiple micronutrient deficiencies remain a major public health concern among pregnant women in Ethiopia. Multiple Micronutrient Supplementation (MMS) has been shown to improve maternal and neonatal outcomes. However, its effectiveness to improve maternal hemoglobin level remains suboptimal. This trial was designed to evaluate the effectiveness, acceptability, and barriers and facilitators of MMS among pregnant women. The primary objective was to determine the impact of IFA vs. MMS interventions on hemoglobin, while secondary objectives included assessing acceptability toward MMS uptake. There are MMS and IFA clusters under a big trial by the Ethiopian Ministry of Health to assess the effectiveness of MMS to improve low birth weight. By selecting study participants from the sampled study area by the Ethiopian Ministry of Health, we want to assess the effectiveness of multiple micronutrient supplementation versus iron and folic acid intervention to improve the maternal hemoglobin level among pregnant women attending antenatal care in Ethiopia. How effective MMS is at improving maternal hemoglobin vs. IFA. This study is a nested trial to registration (NCT05708183).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Effectiveness study
Anticipated trial start date 01/01/2025
Actual trial start date 01/01/2025
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 840
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multiple Micronutrient Supplementation For MMS, the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation is used that contains 15 essential vitamins and minerals, including Retinol (Vitamin A-acetate) 800 µg, Vitamin E (as vitamin E-acetate) 10 mg, and Vitamin D (as Cholecalciferol) 200 IU: Vitamin B1 (Thiamine mononitrate) 1.4 mg; Vitamin B2 (As Riboflavin) 1.4 mg; Vitamin B3 (As Nicotinamide) 18 mg; Vitamin B6 (as Pyridoxine) 1.9 mg; Vitamin B12 (as Cyanocobalamin) 2.6 mg; Folic Acid 400 µg; Vitamin C (As Ascorbic Acid) 70 mg; Iron (As ferrous sulfate) 30 mg; Zinc (As zinc sulfate) 15 mg; Copper (As Copper Sulfate) 2 mg; Selenium (as Sodium selenite) 65 µg; and Iodine (as Potassium Iodate) 150 µg. 4-6 months In the intervention cluster, as per the guideline, MMS is a daily dose of 15 essential vitamins and minerals provided to ensure that expectant mothers receive more of the essential nutrients that contribute to healthier pregnancies and provide better birth outcomes, and it offers a comprehensive solution to bridge the nutritional gap and positively impact birth outcomes. Bottles of MMS are given to women to take home for daily use throughout their pregnancy period, and if they remain in the bottle after delivery, it is possible to take the remaining tablets during the lactation period. The control cluster will use IFA as the usual treatment, which is being provided in regular ANC. 420
Control Group Iron Folic Acid 60mg 4-6months Iron-Folic Acid (IFA) supplementation, the standard supplementation, is a key component of maternal health services in Ethiopia, aimed at preventing iron-deficiency anemia. The national guidelines for pregnancy involve taking IFA supplements daily throughout the pregnancy, with a focus on early initiation, ideally starting at the first Antenatal Care (ANC) and similar follow-up with MMS. 420 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- A pregnant woman attends ANC in their 1st trimester in selected study areas. - A Pregnant Woman attends ANC in selected study areas who are enrolled in other clinical trial Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2026 St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe
Ethics Committee Address
Street address City Postal code Country
Switzerland Addis Ababa 1271 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/12/2022 Ethiopian Public Health Institute
Ethics Committee Address
Street address City Postal code Country
Switzerland Addis Ababa 1242 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean maternal hemoglobin Baseline and endline
Secondary Outcome Acceptability at endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EPHI Switzerland Addis Ababa 1242 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
EPHI Addis Ababa ADDIS ABABA 1242 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EPHI Addis Ababa Addis Ababa 1242 Ethiopia Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Zewdie Aderaw Alemu Addis Ababa ADDIS ABABA Ethiopia
Masresha Tessema Addis Ababa Addis Ababa 1242 Ethiopia
Seman K. OUsman Addis Ababa Addis Ababa Ethiopia
Atkure Defar Addis Ababa Addis Ababa 1242 Ethiopia
Bedasa Tesema Addis Ababa ADDIS ABABA 1242 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edosa Gutema idoamante07@gmail.com +251911995580 Swezerland street
City Postal code Country Position/Affiliation
Addis Ababa 1242 Ethiopia St Paul Hospital Millenium Medical College
Role Name Email Phone Street address
Scientific Enquiries Zewdie Aderaw Alemu zewdie.aderaw@sphmmc.edu.et +251911550926 Switzerland
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia St Paul Hospital Millenium Medical College
Role Name Email Phone Street address
Public Enquiries Seman K Ousman seman.kedir@sphmmc.edu.et +251911176515 Switzerland
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia St Paul Hospital Millenium Medical College
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the finding and public a manuscript within 12 months of study completion Clinical Study Report,Informed Consent Form Up to January 2027 NA
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 12/07/2026 revised The study aimed at the following objectives: - The primary objective of this study is to assess the effect of MMS versus IFA supplementation on maternal hemoglobin levels among pregnant women attending antenatal care clinics in Ethiopia - Secondary objectives are ­- To assess the acceptability of MMS and determinant factors - To explore the barriers and facilitators influencing implementation to MMS among pregnant women attending ANC, healthcare provider perspectives, health managers, and decision-makers in Ethiopia Multiple micronutrient deficiencies remain a major public health concern among pregnant women in Ethiopia. Multiple Micronutrient Supplementation (MMS) has been shown to improve maternal and neonatal outcomes. However, its effectiveness to improve maternal hemoglobin level remains suboptimal. This trial was designed to evaluate the effectiveness, acceptability, and barriers and facilitators of MMS among pregnant women. The primary objective was to determine the impact of IFA vs. MMS interventions on hemoglobin, while secondary objectives included assessing acceptability toward MMS uptake. There are MMS and IFA clusters under a big trial by the Ethiopian Ministry of Health to assess the effectiveness of MMS to improve low birth weight. By selecting study participants from the sampled study area by the Ethiopian Ministry of Health, we want to assess the effectiveness of multiple micronutrient supplementation versus iron and folic acid intervention to improve the maternal hemoglobin level among pregnant women attending antenatal care in Ethiopia. How effective MMS is at improving maternal hemoglobin vs. IFA. This study is a nested trial to registration (NCT05708183).
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 12/07/2026 updated Phase-0 Phase-3
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 17/07/2026 PACTR Admin 01 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/07/2026 updated Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 07/07/2026 update Allocation was determined by the holder of the sequence who is situated off site Central randomisation by phone/fax
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 12/07/2026 updated Central randomisation by phone/fax Allocation Sequence/Code was not concealed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 07/07/2026 description added - A Pregnant Woman attends ANC in their 1st trimester - A pregnant woman attends ANC in their 1st trimester in selected study areas.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 07/07/2026 description added - A Pregnant Woman attends ANC who are enrolled in other clinical trial - A Pregnant Woman attends ANC in selected study areas who are enrolled in other clinical trial
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 07/07/2026 age group added Adult: 18 Year(s)-44 Year(s) Adolescent: 13 Year(s)-17 Year(s), Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/07/2026 update Experimental Group, Multiple Micronutrient Supplementation, 60 mg/daily, 4-6 months, In the intervention cluster, as per the guideline, MMS is a daily dose of 15 essential vitamins and minerals provided to ensure that expectant mothers receive more of the essential nutrients that contribute to healthier pregnancies and provide better birth outcomes, and it offers a comprehensive solution to bridge the nutritional gap and positively impact birth outcomes. Bottles of MMS are given to women to take home for daily use throughout their pregnancy period, and if they remain in the bottle after delivery, it is possible to take the remaining tablets during the lactation period. The control cluster will use IFA as the usual treatment, which is being provided in regular ANC. , 420, Experimental Group, Multiple Micronutrient Supplementation, For MMS, the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation is used that contains 15 essential vitamins and minerals, including Retinol (Vitamin A-acetate) 800 µg, Vitamin E (as vitamin E-acetate) 10 mg, and Vitamin D (as Cholecalciferol) 200 IU: Vitamin B1 (Thiamine mononitrate) 1.4 mg; Vitamin B2 (As Riboflavin) 1.4 mg; Vitamin B3 (As Nicotinamide) 18 mg; Vitamin B6 (as Pyridoxine) 1.9 mg; Vitamin B12 (as Cyanocobalamin) 2.6 mg; Folic Acid 400 µg; Vitamin C (As Ascorbic Acid) 70 mg; Iron (As ferrous sulfate) 30 mg; Zinc (As zinc sulfate) 15 mg; Copper (As Copper Sulfate) 2 mg; Selenium (as Sodium selenite) 65 µg; and Iodine (as Potassium Iodate) 150 µg., 4-6 months, In the intervention cluster, as per the guideline, MMS is a daily dose of 15 essential vitamins and minerals provided to ensure that expectant mothers receive more of the essential nutrients that contribute to healthier pregnancies and provide better birth outcomes, and it offers a comprehensive solution to bridge the nutritional gap and positively impact birth outcomes. Bottles of MMS are given to women to take home for daily use throughout their pregnancy period, and if they remain in the bottle after delivery, it is possible to take the remaining tablets during the lactation period. The control cluster will use IFA as the usual treatment, which is being provided in regular ANC. , 420,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/07/2026 description added Control Group, Iron Folic Acid, 60mg, 4-6months, Similar with MMS, 420, Active-Treatment of Control Group Control Group, Iron Folic Acid, 60mg, 4-6months, Iron-Folic Acid (IFA) supplementation, the standard supplementation, is a key component of maternal health services in Ethiopia, aimed at preventing iron-deficiency anemia. The national guidelines for pregnancy involve taking IFA supplements daily throughout the pregnancy, with a focus on early initiation, ideally starting at the first Antenatal Care (ANC) and similar follow-up with MMS. , 420, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2026 I have attached retrospectively approved IRB letter TRUE, EPHI IRB, Switzerland, Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251912145230, atomsa@ephi.gov.et, 38419_35595_4737.pdf TRUE, EPHI IRB, Switzerland, Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251912145230, atomsa@ephi.gov.et, 38419_35595_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2026 I have attached retrospectively approved IRB letter TRUE, EPHI IRB, Switzerland, Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251912145230, atomsa@ephi.gov.et, 38419_35595_4737.pdf TRUE, EPHI IRB, Switzerland, Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251912145230, atomsa@ephi.gov.et, 38419_35595_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2026 I have attached retrospectively approved IRB letter TRUE, EPHI IRB, Switzerland, Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251912145230, atomsa@ephi.gov.et, 38419_35595_4737.pdf TRUE, St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe, Switzerland, Addis Ababa, 1271, Ethiopia, , 08 May 2026, +2519112732639, irb@sphmmc.edu.et, 38419_35595_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2026 I have attached retrospectively approved IRB letter TRUE, St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe, Switzerland, Addis Ababa, 1271, Ethiopia, , 08 May 2026, +2519112732639, irb@sphmmc.edu.et, 38419_35595_4737.pdf TRUE, St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe, Switzerland, Addis Ababa, 1271, Ethiopia, , 08 May 2026, +251112732639, irb@sphmmc.edu.et, 38419_35595_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2026 The IRB approved yearly and I have attached latest IRB approval letter TRUE, St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe, Switzerland, Addis Ababa, 1271, Ethiopia, , 08 May 2026, +251112732639, irb@sphmmc.edu.et, 38419_35595_4737.pdf TRUE, St. Paul Hospital Millennium Medical College Institutional Research Ethics Review Committe, Switzerland, Addis Ababa, 1271, Ethiopia, , 08 May 2026, +251112732639, irb@sphmmc.edu.et, 38419_35595_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/07/2026 The 1st approved IRB letter by EPHI TRUE, Ethiopian Public Health Institute , Switzerland , Addis Ababa, 1242, Ethiopia, , 26 Dec 2022, +251112133499, ephi@ethionet.et, 38419_40016_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 07/07/2026 age group revised 15 Year(s) 13 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 07/07/2026 age group revised 45 Year(s) 49 Year(s)