Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

March 5, 2021 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario Dr. Jose E Gonzalez UANL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematologic response
Time Frame: 2 month
Normalization of complete blood count (CBC).
2 month
Duration of hematologic response
Time Frame: 6 months
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
Time Frame: Basal, three and six months
Basal, three and six months
Measure levels of methylmalonic acid.
Time Frame: Basal, three and six months
Basal, three and six months
Measure levels of homocysteine.
Time Frame: Basal, three and six months
Basal, three and six months
Evaluate time to hematologic response
Time Frame: 1 month
Time to response after the administration of 10,000mcg hydroxocobalamin
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Study Chair: David Gómez Almaguer, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE17-00023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans for a sharing plan pre-determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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