Home » Trials » SLCTR/2014/032
Randomized Control Trial comparing efficacy of weekly versus daily antenatal oral iron supplementation in preventing anaemia during pregnancy.
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SLCTR Registration Number
SLCTR/2014/032
Date of Registration
The date of last modification
Mar 11, 2020
Trial Status
Scientific Title of Trial
Randomized Control Trial comparing efficacy of weekly versus daily antenatal oral iron supplementation in preventing anaemia during pregnancy.
Public Title of Trial
Weekly versus daily iron during pregnancy.
Disease or Health Condition(s) Studied
Iron supplementation in pregnancy
Scientific Acronym
None
Public Acronym
None
Brief title
Weekly versus daily antenatal oral iron supplementation.
Universal Trial Number
U1111-1158-6008
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is daily antenatal oral iron supplementation better than weekly oral iron supplementation in improving haemoglobin and iron stores in non anaemic pregnant women in Southern Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 3
Intervention(s) planned
Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms.
Arm 1 - Ferrous sulfate 200 mg (Elemental iron 60 mg) + Folic acid 1 mg + Ascorbic acid 100 mg administered daily for a period of 16 to 24 weeks, depending on the gestational period at recruitment (12 to 20 weeks) i.e. up to 34 to 36 weeks , when the second assessment will be done for purposes of the study. However the supplementation will be continued up to 3 months following delivery as per the national recommendations.
Arm 2 - : Ferrous sulfate 200 mg (Elemental iron 60 mg) + Folic acid 1 mg + Ascorbic acid 100 mg administered weekly for a period of 16 to 24 weeks, depending on the gestational period at recruitment (12 to 20 weeks) i.e. up to 34 to 36 weeks , when the second assessment will be done for purposes of the study. However the supplementation will be continued up to 3 months following delivery as per the national recommendations.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ Between 34-36 weeks of gestation ] |
Secondary outcome(s)
|
1.
|
[
|
Target number/sample size
300 (150 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-12-01
Anticipated end date
2016-07-31
Date of first enrollment
2014-12-08
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Department of Obstetrics and Gynecology of the Faculty of Medicine, University of Ruhuna
Regulatory approvals
Status
Approved
Date of Approval
2014-10-01
Approval number
N/A
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Professor Malik Goonewardene
Senior Professor & Head
Department of Obstetrics & Gynaecology,
Faculty of Medicine,
PO box 70, Galle, Sri Lanka.
Tel: +94 91 2246878
malikg@eureka.lk
Contact Person for Public Queries
D I Senadheera.
Registrar (Obstetrics & Gynaecology)
Teaching Hospital, Mahamodara,
Galle, Sri Lanka.
Tel: +94 91 2246878
Mob: +94 716 857242
diluk4@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
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
