Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?
- Conditions
- Iron Deficiency AnemiaB12 Deficiency Anemia
- Interventions
- Registration Number
- NCT04627181
- Lead Sponsor
- Christian Medical College, Vellore, India
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description FCM + placebo Placebo 1. Ferric carboxymaltose: Single dose, 500 mg 2. Placebo: Single dose B12 + placebo Placebo 1. Hydroxycobalamine: Single dose, 1000 mcg 2. Placebo: Single dose Placebo + placebo Placebo 1. Placebo: Single dose 2. Placebo: Single dose FCM + placebo Ferric carboxymaltose 1. Ferric carboxymaltose: Single dose, 500 mg 2. Placebo: Single dose B12 + placebo Hydroxycobalamin 1. Hydroxycobalamine: Single dose, 1000 mcg 2. Placebo: Single dose FCM +B12 Ferric carboxymaltose 1. Ferric carboxymaltose: Single dose, 500 mg 2. Hydroxycobalamine: Single dose, 1000 mcg FCM +B12 Hydroxycobalamin 1. Ferric carboxymaltose: Single dose, 500 mg 2. Hydroxycobalamine: Single dose, 1000 mcg
- Primary Outcome Measures
Name Time Method Mean haemoglobin 30 days Mean haemoglobin measured 30 days after the intervention
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency Baseline 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.
Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis Baseline 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.
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%. Baseline 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.
Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency. Baseline 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.
Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis Baseline 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.
Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy Day 0 Any adverse events attributable to the use of IV ferric carboxymaltoise and/or IM hydroxycobalamin
Trial Locations
- Locations (1)
Christian Medical College, Vellore
🇮🇳Vellore, Tamil Nadu, India