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

Iron Deficiency Anemia Clinical Trial

— ALOHA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627181
• Other study ID #: 12564 (INTERVEN) 29.01.2020
• Status: Recruiting
• Phase: Phase 4
• Start date: November 18, 2020
• Est. completion date: March 2021

Study information

• Verified date: November 2020
• Source: Christian Medical College, Vellore, India
• Contact: Anna T Valson, MD, DM
• Phone: +91-416-2282683
• Email: annavalson[@]cmcvellore.ac.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• B12 Deficiency Anemia
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

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
• 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
• Placebo
Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
• Placebo
Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD

Locations

Country	Name	City	State
India	Christian Medical College, Vellore	Vellore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Christian Medical College, Vellore, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Sensitivity and specificity of red cell anisochromia on peripheral smear for the diagnosis of iron deficiency anemia	Sensitivity and specificity of red cell anisochromia >=25% on the baseline peripheral smear for the diagnosis of iron deficiency anemia. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.	Baseline
Other	Optimal cutoff of baseline serum methylmalonic acid for the diagnosis of B12 deficiency	Optimal cutoff of baseline serum methylmalonic acid for the diagnosis of B12 deficiency. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group.	Baseline
Primary	Mean haemoglobin	Mean haemoglobin measured 30 days after the intervention	30 days
Secondary	Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency	Sensitivity and specificity of baseline peripheral smear hypochromic RBCs >10%, peripheral smear red blood cell anisocytosis > 10%, percentage hypochromic mature red cells (%HYPOm) >6%, reticulocyte hemoglobin content (CHr) < 30 pg, transferrin saturation (TSAT), and serum ferritin, for the diagnosis of iron deficiency anemia. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.	Baseline
Secondary	Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis	Optimum cutoff of baseline %HYPOm and CHr for the diagnosis of iron deficiency anemia using ROC curve analysis. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.	Baseline
Secondary	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%.	Sensitivity and specificity of > 10% hypochromic red blood cells on peripheral blood smear, >10% red blood cell anisocytosis on peripheral blood smear, %HYPOm > 6%, and CHr < 30 pg measured at baseline, for the diagnosis of iron deficiency anemia in participants with baseline TSAT < 30% and TSAT > 30% respectively. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.	Baseline
Secondary	Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.	Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation (>3 percent of neutrophils with =5 lobes or =1 neutrophil with =6 lobes per 100 neutrophils) and cell population data [mean neutrophil volume > 145 fl or mean monocyte volume > 168 fl] for the diagnosis of B12 deficiency. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group.	Baseline
Secondary	Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis	Optimum cutoff of baseline mean neutrophil volume and mean monocyte volume for the diagnosis of B12 deficiency using ROC curve analysis. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by =1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group.	Baseline
Secondary	Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy	Any adverse events attributable to the use of IV ferric carboxymaltoise and/or IM hydroxycobalamin	Day 0