Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
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|ClinicalTrials.gov Identifier: NCT03372447|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Megaloblastic Anemia Nos Pernicious Anemia||Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia|
|Actual Study Start Date :||December 27, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Megadose multivitamin complex
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
Other Name: Bedoyecta Tri
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372447
|Contact: David Gómez Almaguer, MD||52 81 email@example.com|
|Contact: César O Pezina Cantú, MDfirstname.lastname@example.org|
|Hospital Universitario Dr. Jose E Gonzalez UANL||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: David Gomez-Almaguer, MD 52 8183488510 email@example.com|
|Contact: César O Pezina-Cantú, MD 52 8115273932 firstname.lastname@example.org|
|Principal Investigator: David Gomez-Almaguer, MD|
|Study Chair:||David Gómez Almaguer, MD||Hospital Universitario Dr. José Eleuterio González|