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Trial registered on ANZCTR


Registration number
ACTRN12618001483246
Ethics application status
Approved
Date submitted
29/08/2018
Date registered
4/09/2018
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Heme-bound iron (Optifer) versus intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia
Scientific title
Heme-bound iron (Optifer) versus intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia
Secondary ID [1] 295941 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anemia with pregnancy 309446 0
Condition category
Condition code
Blood 308288 308288 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This comparative study designed to compare the efficacy and tolerability of the heme-bound iron Optifer (HIO) versus iron saccharate complex (Ferosac) in treatment of pregnancy associated iron deficiency anemia.
Studied women will receive either heme-bound iron Optifer (HIO) tablets (Per Oral (PO) group) or intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia.
The Optifer tablets contain 18 mg heme-bound iron. Each tablet of Optifer increases the serum iron by 3.15 mg and women in the Optifer group will receive two tablets twice daily 1 tablet morning and 1 tablet evening (according to manufacturer instructions) for at least equal or more than 3 months.
Women in the intravenous group will receive the calculated intravenous iron dose according to the formula; total iron needed in mg = 2.4 × pre-pregnancy weight in kg × (target hemoglobin concentration - actual hemoglobin concentration) gm/dl + 500 mg. Twelve (12) gm/dl is the target hemoglobin concentration and 2.4 is a correction factor, while the 500 is the amount of stored iron in adult pregnant women. The calculated total intravenous iron dose will be given over 6-8 sessions, in each session 200 mg of iron saccharate complex will be diluted in normal saline and given by intravenous infusion over one hour every other day.
The adherence to the intervention will be checked by the empty tablets package in the oral group and by the hospital admission records in the intravenous group.
The adherence to treatment in intravenous group will be checked by the hospital admission records.
This study is non-randomized study; the first half of enrolled women will receive oral iron Optifer and the second half of enrolled women will receive intravenous iron.
In addition; women who will develop intolerance or gastric upset to oral iron Optifer will shifted to intravenous iron preparation.
Intervention code [1] 312266 0
Treatment: Drugs
Comparator / control treatment
Control group will receive intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia.
Women in the intravenous group will receive the calculated intravenous iron dose according to the formula; total iron needed in mg = 2.4 × pre-pregnancy weight in kg × (target hemoglobin concentration - actual hemoglobin concentration) gm/dl + 500 mg. Twelve (12) gm/dl is the target hemoglobin concentration and 2.4 is a correction factor, while the 500 is the amount of stored iron in adult pregnant women. The calculated total intravenous iron dose will be given over 6-8 sessions, in each session 200 mg of iron saccharate complex will be diluted in normal saline and given by intravenous infusion over one hour every other day.
Control group
Active

Outcomes
Primary outcome [1] 307260 0
The efficacy of the heme-bound iron Optifer (HIO) compared to intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia.
Outcome assessed through laboratory tests including; complete blood picture and serum ferritin.
Timepoint [1] 307260 0
4-6 months post-enrolment (final result).
While, the studied pregnant women with iron deficiency anemia will be checked in the ante-natal clinics every 2-4 weeks for monitoring of the treatment related side effects and complete blood picture monthly.
Secondary outcome [1] 351296 0
The tolerability and the side effects (as gastrointestinal upset, metallic taste, constipation and/or intolerance) related to the heme-bound iron Optifer (HIO) and intravenous iron (Ferosac) using medications related side effects questionnaire designed specially for this study.
Timepoint [1] 351296 0
4-6 months post-enrolment (final result).
While, the studied pregnant women with iron deficiency anemia will be checked in the ante-natal clinics every 2-4 weeks for monitoring of the treatment related side effects and complete blood picture monthly.

Eligibility
Key inclusion criteria
Inclusion criteria includes; pregnant women more than or equal 20 years` old, 14-26 weeks` gestation, with hemoglobin less than or equal 10 gm/dl (8-10 gm/dl).
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women with anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy will excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20815 0
Kuwait
State/province [1] 20815 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 300538 0
Hospital
Name [1] 300538 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 300538 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 300538 0
Kuwait
Primary sponsor type
Hospital
Name
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 300022 0
Individual
Name [1] 300022 0
Ibrahim A. Abdelazim
Address [1] 300022 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 300022 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301331 0
Head of the Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 301331 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 301331 0
Kuwait
Date submitted for ethics approval [1] 301331 0
09/07/2018
Approval date [1] 301331 0
17/07/2018
Ethics approval number [1] 301331 0

Summary
Brief summary
Pregnant women with pregnancy associated iron deficiency anemia and hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) will included in this study to receive either Optifer tablets (Per Oral (PO) group) or intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia.
Women in the per oral (PO) group will receive heme-bound iron Optifer (HIO) tablets twice daily (1 tablet morning and 1 tablet evening) not related to meals for more than or equal 3 months till hemoglobin level of 11-12 gm/dl then one tablet daily as maintenance dose.
Women in the intravenous (IV) group will receive the calculated intravenous iron dose, which will be given over 6-8 sessions, in each session 200 mg of iron saccharate complex (Ferosac) will be diluted in normal saline and given by intravenous infusion over one hour every other day.
The Optifer and intravenous iron (Ferosac) efficacy will checked by comparing the pre-treatment hemoglobin, ferritin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) and the primary outcome measures; the efficacy of the heme-bound iron Optifer (HIO) compared to intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia.
Trial website
Trial related presentations / publications
Public notes
Attachments [2] 3063 3063 0 0

Contacts
Principal investigator
Name 86646 0
Prof Ibrahim A. Abdelazim
Address 86646 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86646 0
Kuwait
Phone 86646 0
+96566551300
Fax 86646 0
Email 86646 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 86647 0
Prof Ibrahim A. Abdelazim
Address 86647 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86647 0
Kuwait
Phone 86647 0
+96566551300
Fax 86647 0
Email 86647 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 86648 0
Prof Ibrahim A. Abdelazim
Address 86648 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86648 0
Kuwait
Phone 86648 0
+96566551300
Fax 86648 0
Email 86648 0
dr.ibrahimanwar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Line-by line data collected from each participant.
When will data be available (start and end dates)?
Start date 3/6/2019
End date 30/4/2020
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
By what mechanism will data be made available?
Access subject to approvals by principal investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
Summary results
Not applicable