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.

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.