Megaloblastic Anemia Nos, Pernicious Anemia
Conditions
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.
Interventions
DRUGHydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematologic response | 2 month | Normalization of complete blood count (CBC). |
| Duration of hematologic response | 6 months | Duration of response (months) after the administration of megadose of hydroxocobalamin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time to response after the administration of 10,000mcg hydroxocobalamin |
Countries
Mexico
Outcome results
None listed