Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Overview

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

Full Title of Study: “Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2018

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.

Interventions

  • Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
    • Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

Arms, Groups and Cohorts

  • Experimental: Megadose multivitamin complex
    • Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Clinical Trial Outcome Measures

Primary Measures

  • Hematologic response
    • Time Frame: 2 month
    • Normalization of complete blood count (CBC).
  • Duration of hematologic response
    • Time Frame: 6 months
    • Duration of response (months) after the administration of megadose of hydroxocobalamin

Secondary Measures

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

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Dr. Jose E. Gonzalez
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Gomez Almaguer, Principal Investigator / Head of Hematology Department/MD – Hospital Universitario Dr. Jose E. Gonzalez
  • Overall Official(s)
    • David Gómez Almaguer, MD, Study Chair, Hospital Universitario Dr. José Eleuterio González

Citations Reporting on Results

Sanz-Cuesta T, Gonzalez-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-Gonzalez I, Martin-Fernandez J, Escortell-Mayor E, Rodriguez-Salvanes F, Garcia-Solano M, Gonzalez-Gonzalez R, Martin-de la Sierra-San Agustin MA, Olmedo-Luceron C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Perez A, Garcia-de Blas-Gonzalez F, Marino-Suarez JE, Rodriguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blazquez M, Rodriguez-Monje MT, Soto-Diaz S, Martin-Iglesias S, Rodriguez-Gonzalez R, Breton-Lesmes I, Vicente-Herrero M, Sanchez-Diaz J, Gomez-Gascon T, Drake-Canela M, Asunsolo-del Barco A; 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.

Stabler SP. Vitamin B12 deficiency. N Engl J Med. 2013 May 23;368(21):2041-2. doi: 10.1056/NEJMc1304350. No abstract available.

Green R. Vitamin B12 deficiency from the perspective of a practicing hematologist. Blood. 2017 May 11;129(19):2603-2611. doi: 10.1182/blood-2016-10-569186. Epub 2017 Mar 30.

Sharabi A, Cohen E, Sulkes J, Garty M. Replacement therapy for vitamin B12 deficiency: comparison between the sublingual and oral route. Br J Clin Pharmacol. 2003 Dec;56(6):635-8. doi: 10.1046/j.1365-2125.2003.01907.x.

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