Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

NCT03372447 | Completed Phase 4 DMC

• 1 other identifier: HE17-00023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Megaloblastic Anemia Nos; Pernicious Anemia

Outcome Measures

Primary Outcomes (2)

• Hematologic response

  Normalization of complete blood count (CBC).

  2 month

• Duration of hematologic response

  Duration of response (months) after the administration of megadose of hydroxocobalamin

  6 months

Secondary Outcomes (4)

• Measure levels of hydroxocobalamin

  Basal, three and six months

• Measure levels of methylmalonic acid.

  Basal, three and six months

• Measure levels of homocysteine.

  Basal, three and six months

• Evaluate time to hematologic response

  1 month

Study Arms (1)

Megadose multivitamin complex

EXPERIMENTAL

Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Interventions

Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg DRUG

Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

Also known as: Bedoyecta Tri

Megadose multivitamin complex

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (4)

• 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.

  PMID: 22650964 RESULT

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

  PMID: 23697526 RESULT

• 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.

  PMID: 28360040 RESULT

• 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.

  PMID: 14616423 RESULT

MeSH Terms

Conditions

Anemia, Megaloblastic; Anemia, Pernicious

Interventions

Hydroxocobalamin; Thiamine; Pyridoxine

Condition Hierarchy (Ancestors)

Anemia, Macrocytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Vitamin B 12 Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 12; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Pyrimidines; Vitamin B 6; Picolines; Pyridines

Study Officials

• David Gómez Almaguer, MD

  Hospital Universitario Dr. José Eleuterio González

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Head of Hematology Department/MD

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 13, 2017
• Study Start: December 27, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)