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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372447
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : December 27, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

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Contacts and Locations
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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


Locations
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Mexico
Hospital Universitario Dr. Jose E Gonzalez UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Study Chair: David Gómez Almaguer, MD Hospital Universitario Dr. José Eleuterio González
More Information
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Publications of Results:
Sanz-Cuesta T, González-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-González I, Martín-Fernández J, Escortell-Mayor E, Rodríguez-Salvanés F, García-Solano M, González-González R, Martín-de la Sierra-San Agustín MÁ, Olmedo-Lucerón C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Pérez A, García-de Blas-González F, Mariño-Suárez JE, Rodríguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blázquez M, Rodríguez-Monje MT, Soto-Díaz S, Martín-Iglesias S, Rodríguez-González R, Bretón-Lesmes I, Vicente-Herrero M, Sánchez-Díaz J, Gómez-Gascón T, Drake-Canela M, Asúnsolo-del Barco Á; OB12 Group. Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12). BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394.

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Responsible Party: David Gomez Almaguer, Principal Investigator / Head of Hematology Department/MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03372447    
Other Study ID Numbers: HE17-00023
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans for a sharing plan pre-determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Pernicious
Anemia, Megaloblastic
Hematologic Diseases
Anemia, Macrocytic
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Thiamine
Pyridoxine
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hematinics