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.: PACTR202310850205072 Date of Approval: 24/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of iron supplementation on fatigue and physical performance in young women with iron-deficiency anemia
Official scientific title The effect of 8 weeks of ferrous sulfate supplementation on fatigue and physical performance in young women with iron deficiency anemia
Brief summary describing the background and objectives of the trial Affecting around one-third of the world's population, anemia is considered the most common hematological manifestation worldwide. In particular, pre-menopausal women are vulnerable to anemia not only because of menstruation, but also because of low iron intake due to restrictive diets used to lose weight. The most reported symptom of hematological disorders is fatigue resulting from reduced muscle function and diminished endurance capacity. Oral administration of ferrous sulfate is a practical, inexpensive, and effective mean of treating patients with mild to moderate iron deficiency anemia. Thus, the aim of this study was to investigate the effect of 8 weeks of ferrous sulfate supplementation on fatigue and physical performance in young women with iron deficiency anemia.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/10/2023
Actual trial start date
Anticipated date of last follow up 21/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants)
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ferrous sulfate supplementation 494.5 mg/day 8 weeks participants in this study (young women with iron-deficiency anemia) will be invited to take 247.25 mg of ferrous sulfate twice a day for a period of 8 weeks. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pre-menopausal women with iron deficiency anemia, aged between 18 and 35 years Participants treated with oral or parenteral iron supplementation within the last 3 months Smokers Pregnant or breastfeeding women Participants with infections Participants with inflammations (C-reactive protein concentration > 5 mg/L) Participants with hemorrhage or any other comorbidity Adult: 19 Year-44 Year 18 Year(s) 35 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 29/09/2023 Committee of Protection of Persons in South
Ethics Committee Address
Street address City Postal code Country
Road Manzel Chaker Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome muscle strength 24 h before ferrous sulfate supplementation and 24 h after the end of the intervention
Primary Outcome muscle endurance 24 hours before ferrous sulfate supplementation and 24 hours after the end of the intervention
Primary Outcome aerobic capacity fitness 24 hours before ferrous sulfate supplementation and 24 hours after the end of the intervention
Secondary Outcome fatigue 24 hours before ferrous sulfate supplementation and 24 hours after the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
centre sectoriel de formation en cuir et chaussures Sakiet ezzit sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Achraf Harrabi Rue Elain Sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S road el Matar Sfax Tunisia Laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Road Manzel Cheker km 3.5
City Postal code Country Position/Affiliation
Sfax 3013 Tunisia Research laboratory education motricity sport and health
Role Name Email Phone Street address
Principal Investigator Mohammed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Road Elain
City Postal code Country Position/Affiliation
Sfax Tunisia Laboratory EM2S
Role Name Email Phone Street address
Scientific Enquiries Mohammed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Road Elain
City Postal code Country Position/Affiliation
Sfax Tunisia Laboratory EM2S
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after identification (text, tables, figures, and appendices) Informed Consent Form 12 months following article's publication Researchers who provide a methodologically sound proposal
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