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

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian Medical College, Vellore, India
• Treatments: Hydroxocobalamin; Vitamin B 12

Criteria

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