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.
- Conditions
- Iron deficinecy anemia in women with benign gynaecological disorders.
- Registration Number
- CTRI/2014/03/004461
- Lead Sponsor
- Lady Hardinge Medical College
- Brief Summary
Anemia is verycommon in Indian women, with iron deficiency anemia being the most common typeof anemia. Intravenous iron sucrose complex is very commonly usedparenteral preparation next to oral iron therapy in treatment of IDA. The newer parenteral iron preparations thoughshowing high efficacy and safety reports are not widely studied and publishedin Indian women. Intravenous ferric carboxymaltose is one of the most upcoming of the newer parenteralpreparations.
Ferric carboxymaltose (FCM) comprises amacromolecular iron hydroxide complex of polynuclear iron (III) hydroxidetightly bound in a carbohydrate shell. The complex has a molecular weight ofaround 150,000 Daltons. This ensures that little of the product is lost throughrenal elimination.
This design of ferric carboxymaltose ensurescontrolled delivery of iron within cells of reticuloendothelial system andsubsequent delivery to the iron binding proteins ferritin and transferring,with minimal risk of release of large amounts of ionic iron in the serum. Thisavoids the risk of acute toxicity associated with many other iron compounds butallowing large amounts of iron to be delivered. This results in a much widertherapeutic window. As a type I complex, FCM delivers iron gradually and mainly to theRES of the liver. This targeted and slow release accounts for the low toxicityof FCM and the large safety margin between normal and lethal dosing (66 timesthe maximum weekly dose recommended for clinical use and 5 times greater thanthe lethal dose of iron sucrose).
Because of these factors and because of the neutral pH andphysiological osmolarity of the FCM formulation, high doses can be administeredwith good local tolerance.Together with its very low potential for immunogenicity, results inam excellent safety profile and convenience for both patients and medicalprofessionals. The ability to give large doses in a single session will alsoenhance 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.
Baselineassessment will be conducted using a pretested proforma and followingparameters will be recorded – demographic profile, age, detailed history, any symptom suggestive of anemia. Detailedgeneral physical and systemic examination will be performed. Prior to givingiron therapy all females will be dewormed using T. Mebendazole 100mg bd for 3days. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 2)Calculated improvement of haematological parameters in both 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. 3)Subjective improvements in clinical parameters 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. 1)Time taken for improvement of haematological and clinical parameters in both 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 Measures
Name Time Method no secondary outcomes are included in the study. not applicable
Trial Locations
- Locations (1)
Lady Hardinge Medical College
🇮🇳Delhi, DELHI, India
Lady Hardinge Medical College🇮🇳Delhi, DELHI, IndiaDr GarimaPrincipal investigator9910207101dr.garima333@gmail.com