Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

H

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase

Completed
Phase 4

Conditions

Megaloblastic Anemia Nos
Pernicious Anemia

Treatments

Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03372447
HE17-00023

Details and patient eligibility

About

Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia

Full 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 performed weekly during the first month of treatment, after the first month a CBC will be taken monthly for 6 months. Also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.

Enrollment

13 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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

-

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Megadose multivitamin complex
Experimental group
Description:
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Treatment:
Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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