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.: PACTR202309541331083 Date of Approval: 12/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of school based weekly iron-folic acid supplementation on nutrition, school achievement and health
Official scientific title Effect of school-based weekly Iron-Folic acid supplementation on serum ferritin level, school performance, weight change, mental health, and frequency of common morbidity among adolescent girls in Silti Woreda, Southern Ethiopia
Brief summary describing the background and objectives of the trial Adolescence is a golden period of optimal growth and development that requires maximum nutrients and energy. During this period, adolescents have essential physical and psychological needs. Anemia is a global public health problem affecting adolescents in general and adolescent girls in particular, women of childbearing age, pregnant women, and children in developed and developing countries. High rates of iron deficiency anemia are found among adolescents worldwide. Ethiopia is a developing country where there are still high levels of stunting and anemia, which affects the overall productivity, education, and economic growth of the country. Iron deficiency anemia differs between the sexes. Adolescent girls are most at risk for iron deficiency. This is due to the accelerated increase in iron requirements, inadequate dietary intake of iron, menstrual losses, infections, the norm of early marriage, and adolescent pregnancies. Socioeconomic status has also been found to determine the incidence of anemia in adolescents. Adolescents are key to breaking the intergenerational cycle of malnutrition, poverty, and food insecurity. Yet little attention is paid to this group in developing countries, including Ethiopia. As a result, anemia, malnutrition, and adolescent morbidity are widespread problems in economically developing countries like Ethiopia. Weekly iron folic acid supplementation (WIFAS) is recommended for adolescents to reduce anemia, but the extent to which it improves educational attainment, weight change, mental health, and incidence of morbidity among adolescent. Objectives The aim of this study is to investigate the effect of weekly school-based iron-folic acid supplementation on serum ferritin levels, academic performance, linear growth, and incidence of frequent morbidity in adolescent girls.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) WIFAS
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/09/2023
Actual trial start date 26/09/2023
Anticipated date of last follow up 26/02/2024
Actual Last follow-up date 26/02/2024
Anticipated target sample size (number of participants) 306
Actual target sample size (number of participants) 306
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Weekly iron folic acid supplementation 60mg of iron tablet and 0.4mg folic acid 6 months School-based weekly IFA supplementation will be given for six months to the intervention groups, and nothing will be given to the control groups. This intervention group will be compared to the control group to know the effect of interventions. For the supplementation of iron-folic acid, four teachers and two health officer supervisors will be recruited. Then, they will give the iron-folic acid tablet every Tuesday to selected adolescent girls in their school and separate class. The intervention group will be taken a combination of 60 mg of elemental iron and 0.4 mg of folic acid tablet. During the weekly supplementation, the subjects will be followed up by the teachers/health officer to check their general health status/side effects like black stools, nausea, constipation, abdominal cramping, and vomiting. However, these side effects are typically reported only in the first few weeks of use and normally decrease over time, ensure compliance, and answer questions that adolescent girls have. Supplementation of iron-folic acid will be on Tuesday because; this supplementation program may not be affected by Monday absenteeism that is followed by the weekend day. Besides, the tablet will be taken after 1 hour of meal/breakfast and if vomiting happens within 30 minutes of taking the tablet, we will replace another pill. Furthermore, we will consider a 20% loss to follow-up for treatment compliance under the intervention. 153
Control Group no intervention 6 months The control group differentiated from intervention group is not only received WAIFS. Otherwise, the other predictor and measurment is the same for all 153 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In selected schools during the study period, Adolescents who have the willingness to give consent/ascent and whose guardians/parents have the willingness to provide consent to participate in the study will be included. Students who plan to leave the school within the coming 6 months, those who will be diagnosed with anemia, or adolescents with pregnancy, or adolescents with obvious abnormalities (kyphosis and scoliosis) in physical growth, Adolescent diagnosed with anemia, malaria, known dignosed Peptic ulcer disease, Those who have been taking prton pump inhibitors, who have been taking habitual/prescribed micronutrient supplement and iron overload will be excluded. Adolescent: 13 Year-18 Year,Child: 6 Year-12 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 17/08/2023 Jimma University Institute of Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 251 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum ferritin level Baseline and after the intervention completed
Secondary Outcome 1. School performance (continuous) 2. Weight change (continuous) 3. Mental Health status (dichotomous) 4. Frequency of common morbidity (count) base line and after the intervention completed
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
School Silti Silti 251 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma Jimma 251 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Jimma 251 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Werabe University Werabe Werabe 251 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shemsu Kedir shemsukedir6@gmail.com +251932603556 Werabe
City Postal code Country Position/Affiliation
Werabe 251 Ethiopia Werabe University
Role Name Email Phone Street address
Scientific Enquiries Dr. Beyene Wondafrash beyenewondafrash@gmail.com +251911407776 Jimma
City Postal code Country Position/Affiliation
Jimma 251 Ethiopia Jimma University
Role Name Email Phone Street address
Public Enquiries Kalkidan Hassen newewi333@gmail.com +251911370862 Jimma
City Postal code Country Position/Affiliation
Jimma 251 Ethiopia Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data has been collecting during the trail; after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol I will share IDP within 12 months of the completion of the project anyone who wishes to access the data. The information will be shared through emails ,and any information request will be shared by scientific inquiries, public inquires and principal investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
UrL can be added in latter 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