- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372447
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64460
- Hospital Universitario Dr. Jose E Gonzalez UANL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Megadose multivitamin complex
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
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Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hematologic response
Time Frame: 2 month
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Normalization of complete blood count (CBC).
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2 month
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Duration of hematologic response
Time Frame: 6 months
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Duration of response (months) after the administration of megadose of hydroxocobalamin
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure levels of hydroxocobalamin
Time Frame: Basal, three and six months
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Basal, three and six months
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Measure levels of methylmalonic acid.
Time Frame: Basal, three and six months
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Basal, three and six months
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Measure levels of homocysteine.
Time Frame: Basal, three and six months
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Basal, three and six months
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Evaluate time to hematologic response
Time Frame: 1 month
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Time to response after the administration of 10,000mcg hydroxocobalamin
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1 month
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Collaborators and Investigators
Investigators
- Study Chair: David Gómez Almaguer, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hematologic Diseases
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vitamin B Deficiency
- Anemia, Macrocytic
- Vitamin B 12 Deficiency
- Anemia
- Anemia, Pernicious
- Anemia, Megaloblastic
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Hematinics
- Vitamin B 12
- Hydroxocobalamin
- Pyridoxine
- Thiamine
Other Study ID Numbers
- HE17-00023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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