Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Study Overview
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Brief Summary
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Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia

Detailed Description
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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.

Official Title
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Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia

Conditions
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Megaloblastic Anemia Nos, Pernicious Anemia

Intervention / Treatment
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* Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megadose multivitamin complex<br>Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg | Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg<br>* Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.<br>* Other names: Bedoyecta Tri;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic response | Normalization of complete blood count (CBC). | 2 month | 
| Duration of hematologic response | Duration of response (months) after the administration of megadose of hydroxocobalamin | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure levels of hydroxocobalamin |  | Basal, three and six months | 
| Measure levels of methylmalonic acid. |  | Basal, three and six months | 
| Measure levels of homocysteine. |  | Basal, three and six months | 
| Evaluate time to hematologic response | Time to response after the administration of 10,000mcg hydroxocobalamin | 1 month |