Back to resultsMegadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Primary Purpose
Megaloblastic Anemia Nos, Pernicious Anemia
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Sponsored by
About this trial
This is an interventional treatment trial for Megaloblastic Anemia Nos
Eligibility 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
-
Sites / Locations
- Hospital Universitario Dr. Jose E Gonzalez UANL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Megadose multivitamin complex
Arm Description
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Outcomes
Primary Outcome Measures
Hematologic response
Normalization of complete blood count (CBC).
Duration of hematologic response
Duration of response (months) after the administration of megadose of hydroxocobalamin
Secondary Outcome Measures
Measure levels of hydroxocobalamin
Measure levels of methylmalonic acid.
Measure levels of homocysteine.
Evaluate time to hematologic response
Time to response after the administration of 10,000mcg hydroxocobalamin
Full Information
NCT ID
NCT03372447
First Posted
December 5, 2017
Last Updated
March 5, 2021
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT03372447
Brief Title
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Official Title
Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Megaloblastic Anemia Nos, Pernicious Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Megadose multivitamin complex
Arm Type
Experimental
Arm Description
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Intervention Type
Drug
Intervention Name(s)
Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Other Intervention Name(s)
Bedoyecta Tri
Intervention Description
Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
Primary Outcome Measure Information:
Title
Hematologic response
Description
Normalization of complete blood count (CBC).
Time Frame
2 month
Title
Duration of hematologic response
Description
Duration of response (months) after the administration of megadose of hydroxocobalamin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measure levels of hydroxocobalamin
Time Frame
Basal, three and six months
Title
Measure levels of methylmalonic acid.
Time Frame
Basal, three and six months
Title
Measure levels of homocysteine.
Time Frame
Basal, three and six months
Title
Evaluate time to hematologic response
Description
Time to response after the administration of 10,000mcg hydroxocobalamin
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gómez Almaguer, MD
Organizational Affiliation
Hospital Universitario Dr. José Eleuterio González
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Dr. Jose E Gonzalez UANL
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans for a sharing plan pre-determined
Citations:
PubMed Identifier
22650964
Citation
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.
Results Reference
result
PubMed Identifier
23697526
Citation
Stabler SP. Vitamin B12 deficiency. N Engl J Med. 2013 May 23;368(21):2041-2. doi: 10.1056/NEJMc1304350. No abstract available.
Results Reference
result
PubMed Identifier
28360040
Citation
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.
Results Reference
result
PubMed Identifier
14616423
Citation
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.
Results Reference
result
Learn more about this trial
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
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