Health Condition 1: D509- Iron deficiency anemia, unspecified Health Condition 2: D519- Vitamin B12 deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric carboxymaltose (FCM) and placebo: Subjects will receive a single dose of 500 mg FCM as an intravenous infusion in 100 ml normal saline over 1 hour via the dialysis blood line + p
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: All adult prevalent haemodialysis (HD) patients on HD for at least 3 months with haemoglobin < 11 g/dL during the study period.
Exclusion criteria
Exclusion criteria: 1. Blood transfusion, blood loss, infection or surgery or change in haemoglobin by > 1 g/dL in the last 1 month 2. Haemoglobinopathy 3. Cirrhosis 4. Haematological malignancy, myeloproliferative disorder, HIV, HBV or HCV infection 5. Any chronic inflammatory disorder 6. IV iron or oral/IM B12 received in the last 3 months 7. severe hyperparathyroidism (intact parathyroid hormone > 1,000 pg/mL) 8. Pregnancy 9. Age 10. History of asthma or eczema, any history of drug allergy, including allergy to iron preparations 11. History of exposure to chemotherapy or cytotoxic drugs â?? 5-FU, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine 12. History of G-CSF use in the last 1 month 13. General anaesthesia with nitrous oxide in the last 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean haemoglobin Timepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamine therapyTimepoint: Day 0;Optimum cutoff of mean neutrophil volume and mean monocyte volume for diagnosis of B12 deficiency using ROC curve analysis Timepoint: 7 day and 1 month;Optimum cutoff of percentage hypochromic mature red cells and reticulocyte haemoglobin content for the diagnosis of iron deficiency anaemia using ROC curve analysisTimepoint: 7 days and 1 month;Sensitivity and specificity of peripheral blood smear, percentage hypochromic mature red cells and reticulocyte haemoglobin content for the diagnosis of iron deficiency anaemia in two subgroups of patients, those with transferrin saturation less than 30% and those with transferrin saturation more than 30%Timepoint: 7 days and 1 month;Sensitivity and specificity of peripheral smear hypochromic RBCs more than 10%, percentage hypochromic mature red cells more than 6%, reticulocyte haemoglobin content more than 30 pg, transferrin saturation and serum ferritin for the diagnosis of iron deficiency as defined by an increase in corrected reticulocyte index more than 1% at 7 days and or increase in haemoglobin of at least 1 g/dL at 1 month after administration of IV iron in Group 1Timepoint: 7 days and 1 month;Sensitivity and specificity of peripheral smear neutrophil hypersegmentation (more than 3% neutrophils with at least 5 lobes or 1% or more neutrophils with at least 6 lobes), and cell population data (mean neutrophil volume more than 145 fl or mean monocyte volume more than 168 fl) for the diagnosis of B12 deficiency (increase in corrected reticulocyte index more than 1% at 7 days and or at least 1 g/dL increase in haemoglobin 1 month after administration of IM hydroxycobalamine in Group 2Timepoint: 7 days and 1 month | — |
Countries
India
Contacts
Public ContactAnna T Valson
Christian Medical College, Vellore
Outcome results
None listed