Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Phase 4

Completed

• Conditions: Megaloblastic Anemia Nos; Pernicious Anemia
• Interventions: Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

• Registration Number: NCT03372447
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 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 Timeline

• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Study Start: 2017-12-27
• Primary Completion: 2018-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Megadose multivitamin complex	Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg	Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Hospital Universitario Dr. Jose E Gonzalez UANL; 🇲🇽 Monterrey, Nuevo Leon, Mexico