ClinicalTrials.gov
ClinicalTrials.gov Menu

Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03372447
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, 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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : December 27, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019


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 Name: Bedoyecta Tri



Primary Outcome Measures :
  1. Hematologic response [ Time Frame: 2 month ]
    Normalization of complete blood count (CBC).

  2. Duration of hematologic response [ Time Frame: 6 months ]
    Duration of response (months) after the administration of megadose of hydroxocobalamin


Secondary Outcome Measures :
  1. Measure levels of hydroxocobalamin [ Time Frame: Basal, three and six months ]
  2. Measure levels of methylmalonic acid. [ Time Frame: Basal, three and six months ]
  3. Measure levels of homocysteine. [ Time Frame: Basal, three and six months ]
  4. Evaluate time to hematologic response [ Time Frame: 1 month ]
    Time to response after the administration of 10,000mcg hydroxocobalamin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372447


Contacts
Contact: David Gómez Almaguer, MD 52 81 8348-8510 dgomezalmaguer@gmail.com
Contact: César O Pezina Cantú, MD 528115273932 cpezina@gmail.com

Locations
Mexico
Hospital Universitario Dr. Jose E Gonzalez UANL Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: David Gomez-Almaguer, MD    52 8183488510    dgomezalmaguer@gmail.com   
Contact: César O Pezina-Cantú, MD    52 8115273932    cpezina@gmail.com   
Principal Investigator: David Gomez-Almaguer, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Study Chair: David Gómez Almaguer, MD Hospital Universitario Dr. José Eleuterio González

Publications of Results:
Responsible Party: David Gomez Almaguer, Principal Investigator / Head of Hematology Department/MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03372447     History of Changes
Other Study ID Numbers: HE17-00023
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans for a sharing plan pre-determined

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Anemia, Pernicious
Anemia, Megaloblastic
Hematologic Diseases
Anemia, Macrocytic
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Pyridoxine
Pyridoxal
Vitamin B 6
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics