Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Pernicious Anemia Clinical Trial

Official title:

Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372447
• Other study ID #: HE17-00023
• Status: Completed
• Phase: Phase 4
• Start date: December 27, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Anemia
• Megaloblastic Anemia Nos
• Pernicious Anemia

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. Jose E Gonzalez UANL	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Green R. Vitamin B(12) 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. Review. — View Citation

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, Sevilla — View 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. — View Citation

Stabler SP. Vitamin B12 deficiency. N Engl J Med. 2013 May 23;368(21):2041-2. doi: 10.1056/NEJMc1304350. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response	Normalization of complete blood count (CBC).	2 month
Primary	Duration of hematologic response	Duration of response (months) after the administration of megadose of hydroxocobalamin	6 months
Secondary	Measure levels of hydroxocobalamin		Basal, three and six months
Secondary	Measure levels of methylmalonic acid.		Basal, three and six months
Secondary	Measure levels of homocysteine.		Basal, three and six months
Secondary	Evaluate time to hematologic response	Time to response after the administration of 10,000mcg hydroxocobalamin	1 month