Home » Trials » SLCTR/2024/027
Efficacy of different regimens of oral iron therapy in treatment of iron deficiency anaemia; A randomized control trial
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SLCTR Registration Number
SLCTR/2024/027
Date of Registration
The date of last modification
Aug 26, 2024
Scientific Title of Trial
Efficacy of different regimens of oral iron therapy in treatment of iron deficiency anaemia; A randomized control trial
Public Title of Trial
Assessing the efficacy of different regimens of oral iron therapy in improving hemoglobin in patients with iron deficiency anaemia
Disease or Health Condition(s) Studied
Iron deficiency anaemia
Scientific Acronym
None
Public Acronym
None
Brief title
Efficacy of different regimens of oral iron therapy in treatment of iron deficiency anaemia
Universal Trial Number
U1111-1305-5149
Any other number(s) assigned to the trial and issuing authority
P/35/03/2024- Ethics Review Committee, University of Kelaniya
What is the research question being addressed?
Is ferrous fumarate 60mg alternate day or 120 mg alternate day better than 60 mg daily regimen in improving hemoglobin level in iron deficiency anaemia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Data analysts, Outcome assessors
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting - Professorial Medical wards or OPD clinics of the Colombo North teaching hospital, Sri Lanka.
Randomization: All consenting males and females will be randomized using a computer-generated system into 3 groups. 1:1:1 in blocks of 9, stratified by male and female using the ID number given to the patient.
Intervention- Arm 1 - Ferrous fumarate - elemental iron 60mg daily Arm 2 - Ferrous fumarate - elemental iron 60mg alternate day Arm 3 - Ferrous fumarate - elemental iron 120mg alternate day
Masking - Data collectors and outcome adjudicators are blind
Inclusion criteria
All consenting adults, both male and female over 18 years of age Confirmed iron deficiency anaemia with a hemoglobin of 10 g/dL or less and serum ferritin below 50 ng/mL
Exclusion criteria
Patients who are hypersensitive to iron therapy (any ferrous compound) Pregnant and Lactating women Patients with other comorbidities that cause anaemia of chronic disease (Chronic kidney disease, chronic liver disease, connective tissue diseases and malignancies), Any other condition or therapy, which would make patient unsuitable for the trial (Patients on IV iron, patients with ongoing bleeding, patients with mixed deficiency anaemia, patients with malabsorption syndromes/ bariatric surgery, patients on recurrent blood transfusions, patients with haemoglobinopathies)
Primary outcome(s)
|
1.
The mean change in hemoglobin at week 12 from baseline |
[ Week 12 ] |
|
2.
The mean change in serum ferritin |
[ Week 12 ] |
Secondary outcome(s)
|
1.
The proportion of participants who achieved a rise of 2 g/dL or more in haemoglobin at week 12 |
[ Week 12 ] |
|
2.
The mean change in serum ferritin at week 12 from baseline |
[ week 12 ] |
|
3.
Rate of adverse events (List of adverse events can be found in the attached document - Proposal_R3) |
[ Week 12 ] |
Target number/sample size
300 - 100 per arm
Countries of recruitment
Sri Lanka
Anticipated start date
2024-09-01
Anticipated end date
2025-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-05-14
Approval number
P/35/03/2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya |
| Institutional Address: | Ethics Review Committee, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka. |
| Telephone: | 0112961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Professor K. Chamila D. Mettananda
Professor in Pharmacology
Department of Pharmacology,
PO box 6,
Faculty of Medicine,
Thalagolla road,
Ragama
0112961139
0714816310
chamila@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-k-chamila-d-mettananda.html
Contact Person for Public Queries
Professor K. Chamila D. Mettananda
Professor in Pharmacology
Department of Pharmacology,
PO box 6,
Faculty of Medicine,
Thalagolla road,
Ragama
0112961139
0714816310
chamila@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-k-chamila-d-mettananda.html
Primary study sponsor/organization
Faculty of Medicine
University of Kelaniya
PO box 6
Faculty of Medicine,
Thalagolla road,
Ragama
+94 11 2961000
info.med@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
