Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Hematologic response
研究概览
简要总结
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
研究组 & 干预措施
Megadose multivitamin complex
Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
干预措施: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg (Drug)
结局指标
主要结局
Hematologic response
时间窗: 2 month
Normalization of complete blood count (CBC).
Duration of hematologic response
时间窗: 6 months
Duration of response (months) after the administration of megadose of hydroxocobalamin
次要结局
- Measure levels of hydroxocobalamin(Basal, three and six months)
- Measure levels of methylmalonic acid.(Basal, three and six months)
- Evaluate time to hematologic response(1 month)
- Measure levels of homocysteine.(Basal, three and six months)
研究者
David Gomez Almaguer
Principal Investigator / Head of Hematology Department/MD
Hospital Universitario Dr. Jose E. Gonzalez