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

NCT04627181 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Christian Medical College, Vellore, India

    lead OTHER

Principal Investigators

  • Anna T Valson, MD, DM · Christian Medical College, Vellore, India

  • Rizwan Alam, MD · Christian Medical College, Vellore, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627181 on ClinicalTrials.gov