Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Chronic GVHD
研究概览
简要总结
Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell transplantation. Vitamin D deficiency has been shown to be associated with increased risk of chronic GVHD in previous clinical studies. The purpose of this research is to investigate the effect of vitamin D supplementation in patients undergoing hematopoietic stem cell transplantation
详细描述
Hematopoietic stem cell transplant candidates are randomized to vitamin D supplementation or usual care. Five milligrams (200,000 IU) of cholecalciferol is injected to intervention group before stem cell transplantation. Additional supplementation of cholecalciferol during follow-up period is determined according to the level of 25(OH)D3. The primary outcome is the incidence of chronic GVHD which is determined according to IBMTR criteria. The secondary outcome consists of the incidence of acute GVHD, incidence and severity of vitamin D deficiency, and serum concentration of 25(OH)D3. Study investigators expect that supplementation of vitamin D may improve the outcome of stem cell transplantation by reducing the incidence of chronic GVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with ≥ 18 years old
- •Diagnosed with hematologic maligancies
- •Planned to undergo allogeneic stem cell transplantation
排除标准
- •Hypercalcemia (ionized serum calcium level [iCa] > 1.3 mmol/L, corrected serum calcium level > 10.5 mg/dL)
- •Impaired renal function (Serum creatinine ≥ 2.4 mg/dL)
- •Not in complete remssion (except for myelodysplastic syndrome and myeloproliferative neoplasm)
- •Consent withdrawal
- •Considered inadequate under investigator's discretion
研究组 & 干预措施
Cholecalciferol
Cholecalciferol 5mg (200,000 IU)
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Chronic GVHD
时间窗: Up to 1 year
Events will be graded according to IBMTR criteria
次要结局
- Acute GVHD(Up to 100 days)
- Vitamin D deficiency(Up to 1 year)
- 25(OH)D3(Up to 1 year)
研究者
Youngil Koh
Principal Investigator
Seoul National University Hospital