NCT04627181

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Christian Medical College, Vellore, India · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Iron Deficiency Anemia
• B12 Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	Single dose of ferric carboxymaltose (Encicarb, Emcure Pharmaceuticals Ltd., Pune, India) 500 mg administered intravenously in 100 ml normal saline over 1 hour via the dialysis blood line immediately following HD
DRUG	Hydroxycobalamin	Single dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately following HD
DRUG	Placebo	Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
DRUG	Placebo	Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-11-13
• Last updated: 2021-01-29

Locations

1 site across 1 country: India