Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Overall Status

Completed

CT.gov ID

NCT03372447

Collaborator

(none)

Enrollment

Location

Arm

23.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Megaloblastic Anemia Nos Pernicious Anemia	Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg	Phase 4

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 27, 2017

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Megadose multivitamin complex Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg	Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg. Other Names: Bedoyecta Tri

Arm

Intervention/Treatment

Experimental: Megadose multivitamin complex

Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

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

Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

Other Names:

Bedoyecta Tri

Outcome Measures

Primary Outcome Measures

Hematologic response [2 month]
Normalization of complete blood count (CBC).
Duration of hematologic response [6 months]
Duration of response (months) after the administration of megadose of hydroxocobalamin

Secondary Outcome Measures

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 [1 month]
Time to response after the administration of 10,000mcg hydroxocobalamin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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