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Trial registered on ANZCTR


Registration number
ACTRN12619000230156
Ethics application status
Approved
Date submitted
9/02/2019
Date registered
18/02/2019
Date last updated
22/10/2021
Date data sharing statement initially provided
18/02/2019
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ferric Polymaltose Complex (Ferose) in Treatment of Iron Deficiency and Iron Deficiency Anemia with Pregnancy
Scientific title
Ferric Polymaltose Complex (Ferose) in Treatment of Iron Deficiency and Iron Deficiency Anemia with Pregnancy
Secondary ID [1] 297347 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency with pregnancy 311466 0
Iron deficiency anemia 311527 0
Condition category
Condition code
Reproductive Health and Childbirth 310106 310106 0 0
Antenatal care
Blood 310219 310219 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women with iron deficiency (ferritin <15 ug/l) and iron deficiency anemia with pregnancy (haemoglobin less than 10 gm/dl (7-10 gm/dl mild to moderate)) will be included in this study after informed consent.
Diagnosis of iron deficiency based on serum ferritin (ug/l) and iron deficiency anemia based on; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH).
Studied women will be treated with the (Ferose tablets) ferric hydroxide-polymaltose complex tablets (3 times daily) for correction of iron deficiency and iron deficiency anemia for 3 months.
Each tablet of Ferose contains 100 mg of ferric hydroxide-polymaltose complex.
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 iron deficiency and iron deficiency anemia using the laboratory parameters; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH).
The pre-treatment ferritin, hemoglobin, red blood cells red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH) will be compared by the 3 months` post-treatment values to evaluate the efficacy of ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency and iron deficiency anemia with pregnancy in the same study group of women.
Intervention code [1] 313595 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319000 0
The efficacy of the ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency with pregnancy, using the serum ferritin assay (laboratory test).
Timepoint [1] 319000 0
Every 2-4 weeks for 4 months post-enrolment (primary endpoint).
Primary outcome [2] 319049 0
The efficacy of the ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency anaemia with pregnancy, Correction of iron deficiency anaemia after the treatment detected using complete blood picture (laboratory test).
Complete blood picture contains; serum haemoglobin. mean corpuscular volume and mean corpuscular haemoglobin.
Timepoint [2] 319049 0
Every 2-4 weeks for 4 months post-enrolment (primary endpoint).
Secondary outcome [1] 366696 0
The side effects related to ferric hydroxide-polymaltose complex tablets using the medication related side effects questionnaire specially for this study.
Example of the ferric hydroxide-polymaltose complex side effects: metallic taste, gatrointestinal upset and constipation.

Timepoint [1] 366696 0
Assessed every 2-4 weeks for 4 months post-enrolment.

Eligibility
Key inclusion criteria
Inclusion criteria include; pregnant women equal or more than 20 years old, 14-26 weeks` gestation with serum ferritin less than 15 ug/l and hemoglobin less than or equal 10 gm/dl.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include; pregnant women with intolerance or hypersensitivity to oral iron and/or anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy.

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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 21268 0
Kuwait
State/province [1] 21268 0
Ahmadi hospital, Ahmadi, Kuwait.
Country [2] 21469 0
Kazakhstan
State/province [2] 21469 0
Aktobe, Kazkhastan

Funding & Sponsors
Funding source category [1] 301912 0
Hospital
Name [1] 301912 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 301912 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 301912 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] 301666 0
Individual
Name [1] 301666 0
Ibrahim A. Abdelazim
Address [1] 301666 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 301666 0
Kuwait
Secondary sponsor category [2] 302693 0
University
Name [2] 302693 0
West Kazakhstan Medical University.
Address [2] 302693 0
Maresyev St postcode, 030012, Aktobe, Kazakhstan.
West Kazakhstan State Medical University (WKSMU), Aktobe, Kazakhstan.
Country [2] 302693 0
Kazakhstan
Other collaborator category [1] 280686 0
Individual
Name [1] 280686 0
Svetlana Shikanova
Address [1] 280686 0
Maresyev St postcode, 030012, Aktobe, Kazakhstan.
West Kazakhstan State Medical University (WKSMU), Aktobe, Kazakhstan.
Country [1] 280686 0
Kazakhstan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302598 0
Head of the Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 302598 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 302598 0
Kuwait
Date submitted for ethics approval [1] 302598 0
02/12/2018
Approval date [1] 302598 0
09/12/2018
Ethics approval number [1] 302598 0

Summary
Brief summary
Pregnant women with iron deficiency (ferritin <15 ug/l) and iron deficiency anemia with pregnancy (haemoglobin less than 10 gm/dl (7-10 gm/dl mild to moderate) will be included in this study after informed consent.
Diagnosis of iron deficiency based on serum ferritin (ug/l) and iron deficiency anemia based on; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH).
Studied women will be treated with the ferric hydroxide-polymaltose complex tablets for correction of iron deficiency and iron deficiency anemia for 3 months.
The pre-treatment ferritin, hemoglobin, red blood cells red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH) will be compared by the 3 months` post-treatment values to evaluate the efficacy of ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency and iron deficiency anemia with pregnancy in the same group of women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90770 0
Prof Ibrahim A. Abdelazim
Address 90770 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 90770 0
Kuwait
Phone 90770 0
+96566551300
Fax 90770 0
Email 90770 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 90771 0
Prof Ibrahim A. Abdelazim
Address 90771 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 90771 0
Kuwait
Phone 90771 0
+96566551300
Fax 90771 0
Email 90771 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 90772 0
Prof Ibrahim A. Abdelazim
Address 90772 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 90772 0
Kuwait
Phone 90772 0
+96566551300
Fax 90772 0
Email 90772 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 3/8/2019
Expected end date 3/8/2020
Available to whom?
Available for researchers from the corresponding authors
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
dr.ibrahimanwar@gmail.com
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1330 0
Study protocol
Citation [1] 1330 0
Link [1] 1330 0
Email [1] 1330 0
Other [1] 1330 0
Type [2] 1331 0
Ethical approval
Citation [2] 1331 0
Link [2] 1331 0
Email [2] 1331 0
Other [2] 1331 0
Local departmental Approval of the study
Type [3] 13710 0
Statistical analysis plan
Citation [3] 13710 0
Link [3] 13710 0
Email [3] 13710 0
Other [3] 13710 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary
Iron deficiency (ID) and iron deficiency anemia (IDA) are associated with cognitive decline and an increased risk of maternal depression. In addition, adverse effects of ID and IDA on newborns, preterm labor and intra- uterine fetal growth retardation have been reported . The purpose of this study was to evaluate the effectiveness of ferric hydroxide polymaltosis (FPM) in the treatment of ID and IDA during pregnancy.
Methods: 122 women with ID (ferritin <15 µg / l) and moderate IDA (hemoglobin = 7 and <10 g / dl) during pregnancy were enrolled in the study . The studied women took FPM tablets for at least 3 months. Serum ferritin and hemoglobin concentrations, mean RBC volume (MCV), and mean RBC hemoglobin mass (MCH) before treatment were compared with post-treatment values. Results: The mean concentration of ferritin and hemoglobin before treatment significantly increased from 12.4 ± 5.6 µg / l and 7.8 ± 3.3 g / dl, respectively, to 116.5 ± 6.9 µg / l and 11.1 ± 2, 8 g / dL, respectively, 3 months after FPM treatment (p = 0.02 and 0.0002 respectively). In addition, mean RBC MCV and MCH before treatment increased significantly from 73.5 ± 4.6 fl and 24.2 ± 7.7 pg, respectively, to 94.0 ± 3.8 fl and 31.7 ± 6.3 pg 3 months after FPM treatment, respectively (p = 0.02 and 0.01, respectively).
Polymaltose ferric hydroxide is an effective therapeutic option in the treatment of IDA and ID in pregnant women, because this drug has a high safety profile and slight side effects. The excellent tolerability of FPM is an important advantage because non-adherence to the therapeutic recommendations for the use of oral iron salts is a major obstacle to the successful treatment of ID and IDA during pregnancy.