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Trial registered on ANZCTR


Registration number
ACTRN12618001482257
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) in treatment of pregnancy associated iron deficiency anemia
Scientific title
Heme-bound iron (Optifer) in treatment of pregnancy associated iron deficiency anemia
Secondary ID [1] 295939 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 309445 0
Condition category
Condition code
Blood 308287 308287 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 after informed consent.
Studied women will receive either heme-bound iron Optifer (HIO) tablets twice daily one tablet morning and one tablet evening according to manufacturer instructions (study group) or Trihmeic 350 mg oral ferrous fumarate once daily according to manufacturer instructions (control group) for at least more than or equal 3 months for correction of pregnancy associated iron deficiency anemia.
The adherence to the treatment will be checked by the empty tablet package and laboratory test to check the efficacy of the iron treatment in treating anemia using the hemoglobin, ferritin levels, mean corpuscular volume and mean corpuscular hemoglobin.
The first half of the participants will receive the Trihmeic 350 mg oral ferrous fumarate then the second half of the participants will receive the heme-bound iron Optifer (HIO) tablets.

Intervention code [1] 312265 0
Treatment: Drugs
Comparator / control treatment
Control group will receive Trihmeic 350 mg oral ferrous fumarate tablets once daily for more than or equal 3 months for correction of pregnancy associated iron deficiency anemia.
Control group
Active

Outcomes
Primary outcome [1] 307259 0
The efficacy of the heme-bound iron Optifer (HIO) compared to ferrous fumarate (Trihmeic) in treatment of pregnancy associated iron deficiency anemia.
Outcome assessed through laboratory tests including; complete blood picture and serum ferritin.

Timepoint [1] 307259 0
3-4 months post-enrolment (final result)
while, the pregnant studied 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] 351295 0
The tolerability and the side effects (as gastrointestinal upset, metallic taste, constipation and/or intolerance ) related to the heme-bound iron Optifer and/or Trihmeic tablets using medications related side effects questionnaire designed specially for this study.
Timepoint [1] 351295 0
3-4 months post-enrolment (final result)
while, the pregnant studied 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) due to iron deficincy anemia.
Iron deficiency anemia diagnosed by the following parameters; hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH).
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] 20814 0
Kuwait
State/province [1] 20814 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 300537 0
Hospital
Name [1] 300537 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 300537 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 300537 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] 300021 0
Individual
Name [1] 300021 0
Ibrahim A. Abdelazim
Address [1] 300021 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 300021 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301330 0
Head of the Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 301330 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 301330 0
Kuwait
Date submitted for ethics approval [1] 301330 0
09/07/2018
Approval date [1] 301330 0
17/07/2018
Ethics approval number [1] 301330 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 heme-bound iron (HIO) Optifer tablets twice daily (study group) or Trihmeic 350 mg oral ferrous fumarate once daily (control group) for at least 3 or more months for correction of anemia.
Iron deficiency anemia will be diagnosed by the following parameters; hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH).
The Optifer and Trihemic tablets efficacy will be checked by comparing the pre-treatment hemoglobin, ferritin, mean corpuscular volume and mean corpuscular hemoglobin by the 3 months` post-treatment values.
Primary outcome measures; the efficacy of the Optifer compared to ferrous fumarate (Trihmeic) in treatment of pregnancy associated iron deficiency anemia. While the secondary outcome measures; the tolerability and the side effects related to the Optifer and Trihmeic tablets.




Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86642 0
Prof Ibrahim A. Abdelazim
Address 86642 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country 86642 0
Kuwait
Phone 86642 0
+96566551300
Fax 86642 0
Email 86642 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 86643 0
Prof Ibrahim A. Abdelazim
Address 86643 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country 86643 0
Kuwait
Phone 86643 0
+96566551300
Fax 86643 0
Email 86643 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 86644 0
Prof Ibrahim A. Abdelazim
Address 86644 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country 86644 0
Kuwait
Phone 86644 0
+96566551300
Fax 86644 0
Email 86644 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 31/3/2020
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