Status:
COMPLETED
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Megaloblastic Anemia Nos
Pernicious Anemia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia
Detailed Description
The investigators will administrate a single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg. To assess response to treatment, a complete blood count (CBC) will be pe...
Eligibility Criteria
Inclusion
- Age \>18, All sex Clinical suspicious of megaloblastic anemia ( cytopenias and macrocytosis (CBC), hypersegmented neutrophils and elevated lactate dehydrogenase) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study -
Exclusion
- Administration of hydroxocobalamin in the three years before enrollment Patients with active, uncontrolled psychiatric disorders Severe neurologic deficit Known hematologic malignancy Known coagulation disorder that contraindicates intramuscular injection End-stage kidney disease (GFR \<15ml/min) Chronic liver disease (Child-Pugh B or C) Pregnant patients Known infection of Hepatitis B or C and HIV Diagnosis of myelodysplastic syndrome
- \-
Key Trial Info
Start Date :
December 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03372447
Start Date
December 27 2017
End Date
December 1 2019
Last Update
March 8 2021
Active Locations (1)
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1
Hospital Universitario Dr. Jose E Gonzalez UANL
Monterrey, Nuevo León, Mexico, 64460