A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- GI GVHD
研究概览
简要总结
The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.
详细描述
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.
This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for allogeneic stem cell transplant
- •Vitamin D level < 50 ng/ml
- •Vitamin A level < 75th centile for age
- •Able to tolerate enteral vitamin dose administration
排除标准
- •History of pathologic fractures
- •Known history of nephrocalcinosis or nephrolithiasis
- •Current granulomatous disease
- •ALT > 10X ULN for age prior to administration of vitamin A
- •Ongoing raised intracranial pressure
- •Pregnancy
研究组 & 干预措施
Vitamin D and A Supplementation
Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
干预措施: Vitamin D and A (Dietary Supplement)
Vitamin D Supplementation with Placebo
Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.
干预措施: Vitamin D and Placebo (Dietary Supplement)
结局指标
主要结局
GI GVHD
时间窗: 100 days after transplant
Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
次要结局
- MBI-LCBI(100 days after transplant)
- Treatment Related Mortality(100 days after transplant)
- Overall Survival(1 year after transplant)