| CTRI Number |
CTRI/2021/03/031828 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ferric carboxymaltose and iron sucose complex in treatment of anemia caused by iron deficiency. |
|
Scientific Title of Study
|
Efficacy of Ferric Carboxymaltose and Iron sucrose complex in treatment of Iron deficiency anemia among pregnant women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sunil Raikar |
| Designation |
Senior Resident |
| Affiliation |
Gadag Institute of Medical Sciences |
| Address |
Deparment of OBG,
GIMS,
Gadag
Mallasamudra
Gadag
Gadag
KARNATAKA
582101
India |
| Phone |
08861111948 |
| Fax |
|
| Email |
raikarjodhpurin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sunil Raikar |
| Designation |
Senior Resident |
| Affiliation |
Gadag Institute of Medical Sciences |
| Address |
Deparment of OBG,
GIMS,
Gadag
Mallasamudra
Gadag
KARNATAKA
582101
India |
| Phone |
08861111948 |
| Fax |
|
| Email |
raikarjodhpurin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sunil Raikar |
| Designation |
Senior Resident |
| Affiliation |
Gadag Institute of Medical Sciences |
| Address |
Deparment of OBG,
GIMS,
Gadag
Mallasamudra
Gadag
KARNATAKA
582101
India |
| Phone |
08861111948 |
| Fax |
|
| Email |
raikarjodhpurin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gadag Institute of Medical Sciences, Gadag |
|
|
Primary Sponsor
|
| Name |
Gadag Institute of Medical Sciences |
| Address |
Mallasamudra
Gadag |
| 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 Sunil |
Gadag Institute of Medical Sciences, Gadag |
Room no. 114
Department of OBG,
College Building, GIMS
Mallasamudra
Gadag
Gadag
KARNATAKA |
08861111948
raikarjodhpurin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric Carboxymaltose |
upto 1000mg of ferric carboxymaltose in single sitting. |
| Comparator Agent |
Iron sucrose complex |
200 mg of iron sucrose given on alternate days till target dose is reached. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women with moderate to severe iron deficiency anemia between the gestation period of 20-32 weeks. |
|
| ExclusionCriteria |
| Details |
1) History of Allergic reaction for Intravascular Iron in the past.
2) Hemoglobin less than 4 gm/dl. (as they require Blood transfusion)
3) History of Blood transfusion in the past 3 months.
4) Anemias other than Iron defieciency Anemia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Ferric Carboxymaltose and Iron sucrose complex in correcting Iron deficiency anemia in pregnant women. |
Assessed after 4 months of giving Iron supplementation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 4. To assess the side-effects of both Ferric Carboxymaltose and Iron sucrose complex for treatment of Iron defieciency anemia in pregnant women. |
within 1 day of starting the Iron supplementation |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "448"
Final Enrollment numbers achieved (India)="448" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2021 |
| Date of Study Completion (India) |
31/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Iron deficiency anemia (IDA) is the most common cause of anemia in Antenatal patients. Oral supplementation of iron in pregnant women prevents development of iron deficiency anemia. Sometimes, the pregnant women cannot tolerate oral iron, and develop gastric irritation, metallic taste and nausea. FCM and Iron sucrose complex and FCM are used in treatment of Iron deficiency. FCM has decreased incidence of anaphylactic reactions compared to Iron sucrose complex. This is a prospective non randomised interventional study designed to assess the efficacy of Ferric Carboxymaltose and Iron sucrose complex in antenatal women with iron deficiency anemia. |