Effect of a Single Mega-dose of Vitamin D3 Supplementation on Clinical Course in Non-deficient Patients Admitted in Intensive Care Unit
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 主要终点
- Rate of intensive care unit-acquired infection (ICU-AI)
研究概览
简要总结
A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit (ICU). Patients will be randomly allocated to receive 400,000 IU of VD3 or placebo. They will be followed up until ICU discharge or death or the 15th day of ICU stay. Adverse events that occur during ICU stay is collected. Primary outcome is intensive care unit-acquired infection (ICU-AI), and secondary outcomes are septic shock, organ failure, and ICU-mortality. Plasma 25-hydroxyvitamin D is assessed at baseline and at the end of follow-up. Cox regression models will be applied to test how VD supplementation affects adverse outcomes while adjusting for confounders.
详细描述
The randomized controlled trial aimed to investigate the safety and clinical efficacy of a single mega dose of vitamin D (VD) in patients admitted at intensive care unit (ICU).
Study participants: VD deficient ICU patients
Criteria of inclusion, patients:
- newly admitted (within 24 hours)
- over eighteen,
- able to receive medication orally or through nasogastric tube
- expected to stay more than 72 hours in ICU.
Criteria for non-inclusion and exclusion, patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly admitted (within 24 hours)
- •over eighteen,
- •able to receive medication orally or through nasogastric tube
- •expected to stay more than 72 hours in ICU
- •given consent
排除标准
- •lack of patient's or relatives' consent
- •expected short life or ICU stay (<48 hours)
- •sepsis at admission
- •kidney, liver or intestinal disease
- •hypercalcemia (total calcium>10.6 mg/dL)
- •history of a disorder associated with hypercalcemia (i.e., cancer, tuberculosis, sarcoidosis, hyperparathyroidism, nephrolithiasis)
- •treatment with immunotherapy or vitamin supplements within one year
- •pregnant or breastfeeding women
- •discharge from ICU or death within 72 hours of admission
结局指标
主要结局
Rate of intensive care unit-acquired infection (ICU-AI)
时间窗: 15 days
Infection of blood stream, lower respiratory tract, urinary tract, skin/soft tissue or gastrointestinal tract, which was not present within the first 48 hours of admission into the ICU, which occur during the ICU stay.
次要结局
- urinary calcium:creatinine ratio(15 days)
- Rate of septic shock(15 days)
- Rate of organ failure(15 days)
- Rate of ICU-mortality(15 days)
研究者
Amani Kallel
Associate professor
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose