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.: PACTR202310737053661 Date of Approval: 31/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of iron supplementation on proprioception and postural control in women with iron deficiency anemia.
Official scientific title Effect of 8 weeks of oral ferrous sulfate supplementation on proprioception and postural control in premenopausal women with iron-deficiency anemia.
Brief summary describing the background and objectives of the trial Proprioceptive and postural control impairments have been documented in women with iron deficiency anemia. However, no studies have been conducted on the effect of iron supplementation on proprioception and postural control in patients with iron deficiency anemia. Given that young women are at high risk of this hematological disorder, the aim of this study was to investigate the effect of 8 weeks of fractionated oral supplementation with 494.5 mg ferrous sulfate on postural and proprioceptive performance in premenopausal 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,Musculoskeletal Diseases,Nervous System Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/11/2023
Actual trial start date
Anticipated date of last follow up 28/12/2023
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 160 mg/day of elemental iron (which corresponds ∼494.5 mg/day of ferrous sulfate) 8 weeks Participants (young women suffering from iron deficiency anemia) will be asked to take 494.5 mg of ferrous sulfate (247.25 mg twice daily) for a period of 8 weeks. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
premenopausal women with iron defiecency 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 > 5mg/l) Participants with neurologic or musculoskeletal disease Patients with hemorrhage or any other comorbidities 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 postural control 24 hours before iron supplementation and 24 hours after the end of the procedure.
Primary Outcome proprioceptive acuity 24 hours before iron supplementation and 24 hours after the end of the procedure
Secondary Outcome simple reaction time 24 hours before iron supplementation and 24 hours after the end of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
centre sectoriel de formation professionnelle en cuir et chaussures sakiet ezzit sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Achraf Harrabi rue el Ain Sfax 3013 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory em2s road El matar km 3.5 Sfax 3000 Tunisia Laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Rue El Ain
City Postal code Country Position/Affiliation
sfax 3013 Tunisia Laboratory EM2S
Role Name Email Phone Street address
Public Enquiries Mohamed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Rue El Ain
City Postal code Country Position/Affiliation
Sfax 3013 Tunisia Laboratory EM2S
Role Name Email Phone Street address
Scientific Enquiries Mohamed Achraf Harrabi harrabi.medachraf@gmail.com +21622783292 Rue El Ain
City Postal code Country Position/Affiliation
Sfax 3013 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 indentification (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