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.: PACTR202607761533133 Date of Registration: 13/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Multiple Micronutrient Supplementation to improve the Maternal health outcome among pregnant women attending Antenatal care in Ethiopia
Official scientific title Effectiveness of Multiple Micronutrient Supplementation versus Iron Folic Acid Intervention to improve the Maternal Hemoglobin level among pregnant women attending Antenatal care 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 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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2024
Actual trial start date 01/02/2024
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) 840
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
Control Group Iron Folic Acid During the pregnancy to childbirth a daily tab of Iron folic acid provided from 1st ANC contact to childbirth 420 Active-Treatment of Control Group
Experimental Group Multiple Micronutrient Supplementation From 1st ANC contact to child birth Daily tab of MMS provided From 1st ANC contact to child birth 420
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Pregnant women attending ANC (on their 1st ANC contact) from each clusters _ Pregnant women attending ANC and participating in other trial Adult: 18 Year(s)-44 Year(s) 15 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 Ethiopian Public Health Institute and later approved retrspectively by St Paul Hospital Millenium Medical College IRB
Ethics Committee Address
Street address City Postal code Country
Sweezierland Addis Ababa 1242 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maternal hemoglobin level at baseline and nendline
Secondary Outcome acceptability of MMS at endline, cross sectional
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethiopian Public Health Institute Switzerland street Addis Ababa 1242 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research team Switzerland Addis Ababa 1242 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edosa Switzerland AA Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
Zewdie Aderaw Alemu Addis Ababa ADDIS ABABA Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edosa Gutema idoamante07@gmail.com +251911995580 Addis Ababa
City Postal code Country Position/Affiliation
ADDIS ABABA 1242 Ethiopia Ethiopian Public Health Institute and St Paul Hospital Millenium Medical College
Role Name Email Phone Street address
Principal Investigator Masresha Tessema dr.masresha.tessema@gmail.com +251919782082 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1242 Ethiopia Ethiopian Public Health Institute
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 IPD and summary results will be shared within 12 months of study completion Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within12 months of completion link will be shared
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 Actual trial start date 13/07/2026 PACTR Admin 01 Feb 2024