CTRI/2020/11/029193Completed未知
The role of IV iron and IM vitamin B12 supplementation in the management of anaemic prevalent Indian haemodialysis patients: A parallel group, quadruple blind,placebo-controlled, pragmatic randomized control trial with 2x2 factorial design. - ALOHA
Christian Medical College Vellore0 sites104 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 104
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
- •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 < 18 years
- •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
Investigators
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