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.: PACTR202003545370309 Date of Approval: 20/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Iron-Folic Acid Supplementation for Adolescent Girls
Official scientific title Effect of community-based weekly iron-folic acid supplementation on serum ferritin, folate and hemoglobin level among adolescent girls in southern Ethiopia
Brief summary describing the background and objectives of the trial Adverse effect of micronutrient deficiency during adolescece can persist into adulthood and influence future health. There is no study that evaluated the effect iron-folate supplementation on serom levels of iron and folate biomarkers. Objective of this study is evaluated the effect of community-based weekly iron-folic acid supplementation on serum ferritin, serum folate and blood hemoglobin level among adolescent girls in Southern Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) WIFAS
Disease(s) or condition(s) being studied Apparently healthy adolescent girls aged 10-19 years
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/05/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 25/07/2019
Actual Last follow-up date 30/08/2019
Anticipated target sample size (number of participants) 226
Actual target sample size (number of participants) 204
Recruitment status Completed
Publication URL Not yet
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supplementation of Iron folic acid 60 mg elemental iron and 0.4 mg of folic acid containing one tablet for one day For three months The IFA supplement contains 60 mg elemental iron and 0.4 mg of folic acid containing one tablet in each day for three months 113
Control Group Nothing No three months no 113 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Adolescent girls aged 10-19 years residing in four kebeles of the Humbo district in Wolaita and Hadiya zone - Apparently healthy and not taking medication Adolescent girls with known diseases, anemia, hemoglobin < 12 g/L, malaria positive confirmed with blood, who were with known disease like (HIV/ADIS, TB), anemic, physical and mental disability Adolescent: 13 Year-18 Year 10 Year(s) 19 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 25/09/2018 Institutional review Board of Wolaita Sodo University
Ethics Committee Address
Street address City Postal code Country
Wadu Wolaita Sodo 0138 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum ferritin and serum folate level After three months
Secondary Outcome Hemoglobin, CRP, and weight gain After three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Community level no Humbo Tabala community 0138 Ethiopia
Community level Shone Shone town community 0138 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University and Wolaita Sodo University Arat Kilo for Addis Ababa University and Wadu for wolaita Sodo University Addis Ababa and Wolaita sodo respectively 0138 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Arat Kilo Addis Ababa 1176 Ethiopia University
Secondary Sponsor Wolaita Sodo University Wadu Wolaita Sodo 0138 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr. Abdulhalik Workicho Jimma Jimma 0378 Ethiopia
Dr. Cherinet Abuye Bisrat Gebreal Addis Ababa 0387 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yoseph Halala Handiso yosefhalala@gmail.com +251913233179 Wadu
City Postal code Country Position/Affiliation
Wolaita Sodo 0138 Ethiopia Lecturer at Wolaita Sodo University and PhD Student at Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Kaleab Baye kaleabbaye@gmail.com +251911890489 Arat kilo
City Postal code Country Position/Affiliation
Addis Ababa 1176 Ethiopia Associate professor at Addis Ababa University
Role Name Email Phone Street address
Public Enquiries Tefera Belachew teferabelachew@gmail.com +251917804072 Jimma University
City Postal code Country Position/Affiliation
PO Box 378 0378 Ethiopia Professor at Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share Individual Participant Data at any time . 1. Individual Participant raw data such as age, sex, educational status, health status, nutritional status, intervention the individual took, etc. 2. Individual Participant analyzed, transformed, and aggregated into the summary data will be shared based on the request. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol At any time I have all information of the participants with their code.
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