Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?

The Role Of IV Iron (Ferric Carboxymaltose) And IM Vitamin B12 (Hydroxycobalamin) Supplementation In The Management Of Anaemic Prevalent Indian Hemodialysis Patients: A Parallel Group, Quadruple Blind, Placebo-Controlled, Pragmatic Randomized Control Trial With 2x2 Factorial Design

A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients

Inclusion Criteria:

• All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL

Exclusion Criteria:

• Blood transfusion, blood loss, infection, surgery or change in haemoglobin by > 1 g/dL in the last 1 month
• Hemoglobinopathy
• Cirrhosis
• Hematological malignancy or myeloproliferative disorder
• HIV, HBV or HCV infection
• Any chronic inflammatory disorder
• IV iron or oral/IM B12 received in the last 3 months
• Severe hyperparathyroidism (intact parathyroid hormone > 1,000 pg/mL)
• Pregnancy
• Age < 18 years
• History of asthma or eczema, any history of drug allergy, including allergy to iron preparations
• History of exposure to chemotherapy or cytotoxic drugs - 5-FU, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine
• History of G-CSF use in the last 1 month
• General anaesthesia with nitrous oxide in the last 1 month