Clinical trial NCT04627181: Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency Anemia
B12 Deficiency Anemia
Lead sponsor: Christian Medical College, Vellore, India
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomized to one of four arms: IV ferric carboxymaltose + placebo, IM hydroxycobalamin + placebo, IV ferric carboxymaltose + IM hydroxycobalamin, placebo + placebo
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Mean haemoglobin
timeFrame: 30 days
Secondary outcomes:
measure: Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency
timeFrame: Baseline
measure: Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis
timeFrame: Baseline
measure: Sensitivity and specificity of baseline peripheral blood smear hypochromia, peripheral blood smear anisocytosis and automated red cell indices for the diagnosis of iron deficiency anemia in participants with TSAT < 30% and TSAT > =30%.
timeFrame: Baseline
measure: Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.
timeFrame: Baseline
measure: Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis
timeFrame: Baseline
measure: Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy
timeFrame: Day 0
Other outcomes:
measure: Exploratory: Sensitivity and specificity of red cell anisochromia on peripheral smear for the diagnosis of iron deficiency anemia
timeFrame: Baseline
measure: Optimal cutoff of baseline serum methylmalonic acid for the diagnosis of B12 deficiency
timeFrame: Baseline
Locations:
city: Vellore
country: India
facility: Christian Medical College, Vellore
state: Tamil Nadu
Study officials:
affiliation: Christian Medical College, Vellore, India
name: Anna T Valson, MD, DM
role: STUDY_DIRECTOR
affiliation: Christian Medical College, Vellore, India
name: Rizwan Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: