| CTRI Number |
CTRI/2014/03/004461 [Registered on: 10/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy and safety of two drugs ferric carboxymaltose and iron sucrose complex in the treatment of iron deficiency anemia in patients with gynaecological disorders. |
|
Scientific Title of Study
|
A randomised controlled trial on efficacy and safety of intrvenous ferric carboxymaltose verus intravenous iron sucrose complex in the treatment of iron deficiency anemia in women with benign gynaecological disorders. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1138-1151 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Chaudhry |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
Department of Obstetrics and Gynaecology
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
dr.garima333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratna Biswas |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College Department of Obstetrics and Gynaecology |
| Address |
Lady Hardinge Medical College
Department of Obstetrics and Gynaecology
Central
DELHI
110001
India |
| Phone |
9910207101 |
| Fax |
|
| Email |
graceofganesha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Chaudhry |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College Department of Obstetrics and Gynaecology |
| Address |
Lady Hardinge Medical College
Department of Obstetrics and Gynaecology
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
dr.garima333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College C-604 Shaheed Bhagat Singh Road New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
C- 604 Shivaji Stadium Bus Terminal
Shaheed Bhagat Singh Marg New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Garima |
Lady Hardinge Medical College |
Lady Hardinge Medical College Obstetrics Gynaecology Department New building 2nd Floor C 604 Shivaji Stadium Delhi 110001
New Delhi
DELHI |
9910207101
01123363728
dr.garima333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lady Hardinge Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Iron deficinecy anemia in women with benign gynaecological disorders., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric Carboxymaltose |
Dose 500mg in 250 ml of sterile 0.9 percent normal saline intravenous over fifteen minutes.
Route intravenous
Frequency Once a week
Duration Two weeks
|
| Comparator Agent |
Iron Sucrose Complex |
Dose 200mg in 100ml of sterile 0.9 percent normal saline over 30 minutes.
Frequency thrice a week
Route intravenous
Duration Two weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with benign gynaecological problems above 18 yrs of age with haemoglobin levels from 6 to 8 g%
2. Peripheral blood smear showing microcytic hypochromic picture with anisopoikilocytosis. |
|
| ExclusionCriteria |
| Details |
1)Anemia not due to iron deficiency.
2)Pregnant women will not be included in the study.
3)In cases where iron deficiency anemia is associated with haemolytic/renal or any other primary cause.
4)Anemia with congestive heart failure.
5)Patients who have received parental iron treatment before inclusion in the study.
6)Patients needing blood transfusion during study period will be excluded.
7)Patients with history of allergy to parental iron.
8)Malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Time taken for improvement of haematological and clinical parameters in both groups.
2)Calculated improvement of haematological parameters in both groups.
3)Subjective improvements in clinical parameters in both the groups.
4)Side effects experienced in both the groups. |
1)Time taken for improvement of haematological and clinical parameters in both groups.
2)Calculated improvement of haematological parameters in both groups.
3)Subjective improvements in clinical parameters in both the groups.
4)Side effects experienced in both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes are included in the study. |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The thesis will be published after completion in 2014. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anemia is very
common in Indian women, with iron deficiency anemia being the most common type
of anemia. Intravenous iron sucrose complex is very commonly used
parenteral preparation next to oral iron therapy in treatment of IDA. The newer parenteral iron preparations though
showing high efficacy and safety reports are not widely studied and published
in Indian women. Intravenous ferric carboxymaltose is one of the most upcoming of the newer parenteral
preparations. Ferric carboxymaltose (FCM) comprises a
macromolecular iron hydroxide complex of polynuclear iron (III) hydroxide
tightly bound in a carbohydrate shell. The complex has a molecular weight of
around 150,000 Daltons. This ensures that little of the product is lost through
renal elimination. This design of ferric carboxymaltose ensures
controlled delivery of iron within cells of reticuloendothelial system and
subsequent delivery to the iron binding proteins ferritin and transferring,
with minimal risk of release of large amounts of ionic iron in the serum. This
avoids the risk of acute toxicity associated with many other iron compounds but
allowing large amounts of iron to be delivered. This results in a much wider
therapeutic window. As a type I complex, FCM delivers iron gradually and mainly to the
RES of the liver. This targeted and slow release accounts for the low toxicity
of FCM and the large safety margin between normal and lethal dosing (66 times
the maximum weekly dose recommended for clinical use and 5 times greater than
the lethal dose of iron sucrose). Because of these factors and because of the neutral pH and
physiological osmolarity of the FCM formulation, high doses can be administered
with good local tolerance.
Together with its very low potential for immunogenicity, results in
am excellent safety profile and convenience for both patients and medical
professionals. The ability to give large doses in a single session will also
enhance the cost effectiveness of iron replacement therapies. The study will comprise of 60 subjects who fit into the inclusion criteria after voluntary informed consent. 30 taken as control and 30 as test subjects divided by computerised randomisation.
Baseline
assessment will be conducted using a pretested proforma and following
parameters will be recorded – demographic profile, age, detailed history, any symptom suggestive of anemia. Detailed
general physical and systemic examination will be performed. Prior to giving
iron therapy all females will be dewormed using T. Mebendazole 100mg bd for 3
days. No oral iron supplementation will be given during the study period.
Control subjects will be given iron sucrose intraveinously as 200mg on alternate days. Test subjects will be given intraveinous ferric carboxymaltose 500mg bolus dose intraveinously weekly for two weeks. The comparison will be between 1gm of iron sucrose and 1 gm of ferric carboxymaltose. Samples will be taken on 0 i.e before giving the drug , 7th ,14th, 21st n 28th day aftr the first dose of the drug and biochemical parameters like serum ferritin, complete blood count, liver function tests will be compared. The primary outcomes will be compared as specified. The present study is undertaken to evaluate the efficacy and safety profile of intraveinous ferric carboxymaltose in treating iron deficiency anemia and comparing the response with that intraveinous iron sucrose complex.
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