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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402484795209 Date of Approval: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oral iron folic acid supplementations and pregnancy outcome
Official scientific title To compare the effects of daily and weekly oral iron supplementations on hematological markers, GI side effects, and adherence statuses during pregnancy in healthy non-anemic pregnant women: a randomized control trial
Brief summary describing the background and objectives of the trial Iron deficiency is the main factor that causes anemia in pregnancy. Daily pregnancy supplementation with oral iron folic acid was routine in many countries. Evidence shows that a daily regimen was associated with poor adherence and more side effects, but an intermittent regimen was better tolerated, with low side effects, and similar blood hemoglobin concentrations. World Health Organization recommends an intermittent regimen of Iron folic acid as a context-specific supplement, but the evidence was limited to strengthen this recommendation globally and no evidence exists in Ethiopia so far. This trial aims to answer the following research questions: 1. Does the intermittent have similar anemia incidences as daily oral IFA supplementation during pregnancy for non-anemic women? 2. Does the intermittent have a mean blood hemoglobin level similar to daily oral IFA supplementation among non-anemic pregnant women? 3. Does the risk of gastric episodes lower in intermittent than daily IFA supplementations among non-anemic healthy pregnant women? 4. Does IFA adherence higher in intermittent than daily IFA supplementations among non-anemic healthy pregnant women?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/09/2023
Actual trial start date 04/09/2023
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date 04/09/2024
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants) 165
Recruitment status Recruiting
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Twice weekly oral Iron Folic Acid supplement ferrous sulfate 150 mg (55 mg elemental iron) and folic acid 0.5 mg to be given twice a day and twice a week. 3 months follow up the intervention arm will receive iron-folic acid 110/1 mg two times a week, where 1 tablet contains 55mg elemental iron and 0.5 mg folic acid to be taken one in the morning and the other in the afternoon. The regimen will be received consistently. between the regimen, no regimen or placebo is received. the supplement will start before 25 weeks of gestation. blood samples will be received at the beginning, after 1 month, 2 months, and finally after three months. Side effects, adherences, and anemia incidences will be assessed every month for three months, and at baseline assessment. 85
Control Group daily oral iron folic acid regimen 55 mg elemental iron in 150 mg ferrous sulfate and 0.5 mg folic acid. supplement to be received daily. 3 months Daily Iron folic acid supplementation for three consecutive months, starting from 12-25 weeks of gestation. 85 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- women before 25 weeks of gestation - hemoglobin level at least 11 g/dl - healthy and non-anemic - never received iron-folic acid in the current pregnancy - women who disagree with consent - women who will not attend full antenatal care at the study health facility Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 17/01/2024 Institutional Research Ethics Review Board of Arba Minch University Ethiopia
Ethics Committee Address
Street address City Postal code Country
Nech Sar sub city, Arba Minch, Near Haile Resort of Arba Minch Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood hemoglobin level in g/dl baseline, after one month, two months and three months.
Secondary Outcome incidence of anemia after one month, two months and three months
Secondary Outcome gastric side effects after one month, two months and three months
Secondary Outcome adherence status at one month, two months and three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilfana Hospital Dilfana Arbaminch Ethiopia
Lante Health Center Arbaminch zuria district Lante Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hawassa University Hawassa Hayik, Referal Hospital Hawassa 1560 Ethiopia
Arba Minch University Nech sar,Near to Haile Resort Arba Minch Arba Minch 21 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University Nech sar, near to Haile Resort of Arba Minch Arba Minch 21 Ethiopia Monthly Salary of 15350 birr to investigator, partial research fund, and laboratory facility
Primary Sponsor Hawassa University Hawassa Hayik, Referal Hospital Hawassa 1560 Ethiopia University
Secondary Sponsor Dilfana Hospital Dilfana Arba Minch Ethiopia supplement and laboratory
Secondary Sponsor Lante Health Center Arba Minch Zuria district Lante Ethiopia supplement and laboratory services
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Serawit Lakew lserawit@yahoo.com +251913273829 Limat condominium
City Postal code Country Position/Affiliation
Arba Minch Ethiopia PhD candidate and assistant professor at Arba Minch University
Role Name Email Phone Street address
Public Enquiries Abinet Teshome ableteshe@yahoo.com +251912023009 Secha condominium
City Postal code Country Position/Affiliation
Arba Minch Ethiopia IRB secretary at Arba Minch University and Assistant professor of Biomedical sciences
Role Name Email Phone Street address
Scientific Enquiries Mesay Hailu mesdang216@gmail.com +251903410040 Near Enqulal fabrica in Addis Ababa, Ethiopian Public Health Insttute
City Postal code Country Position/Affiliation
Addis Ababa 1242/5654 Ethiopia Director General at Ethiopian Public Health Institute and Associate professor of Public Health Epidemiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available after completion of the study. Such as Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared publicly through publication of the article in the journal, public presentations in the Universities of Hawassa and Arba Minch, and presentations in the international/national research Symposium. The document will be available in the institutional repository of Hawassa University, College of Medicine and Health Sciences. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Jan 19/2025-Jan 18/2026 Data can be accessed through a request from the main investigator through email: lserawit@yahoo.com/serawit.lakew@amu.edu.et. After publication, results can also be accessed using a search key, such as "IFA intermittent women RCT Arbaminch Ethiopia". Moreover, the Hawassa University institutional repository will also be used to get a full document of the project report using the link: http://etd.hu.edu.et/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://etd.hu.edu.et/ 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