Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient
Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
研究概览
详细说明
There is a high prevalence of vitamin D deficiency in critically ill patient which is associated with muscle wasting and physical disability. Recent study showed that treatment of vitamin D deficiency with high dose vitamin D improved muscle wasting and may prevent further muscle breakdown.
Investigator want to explore whether a high dose vitamin D3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients.
The eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin D3 supplement or placebo, using the computer generated code in conceal envelope.
Vitamin D3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 IU on day 1 and 3 then 50,000 IU on day 5,7,9,12 followed by 150,000 unit per week for 4 week.
Serum 25-Hydroxyvitamin D, 1,25-dihydroxyvitamin D will be measured at baseline (day 0) then day 10 and day 43 after vitamin D supplementation. Moreover, Investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Bangkok、泰国、10400
- Department of Medicine, Faculty of medicine, Ramathibodi Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 - 70 years old
- Expected ICU stay ≥ 48 hrs
Exclusion Criteria:
- Participate in other clinical trial
- Contraindication to receive oral or enteral feeding
- Do not resuscitate /imminent death
- Vegetative state, generalize weakness, denervation of leg, both leg amputation
- Hypercalcemia or Hypercalcemia at risk
- Hyperphosphatemia,
- History of nephrolithiasis
- End stage renal disease on renal replacement therapy
- Pregnancy/lactation
- Consent refusal
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Vitamin D
Dietary Supplement: Vitamin D3
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Vitamin D3 100,000 u per day on day 1,3 then 50,000 u/day on day 5,7,9,12 and continue 50,000 u 3 times/ week for 4 weeks
其他名称：
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安慰剂比较：安慰剂
膳食补充剂：安慰剂
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Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rectus femoris cross-sectional diameer
大体时间：Change from baseline Rectus femoris cross-sectional diameter at day 43
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A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo
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Change from baseline Rectus femoris cross-sectional diameter at day 43
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of hospital stays
大体时间：An expected average of 3 weeks
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Participant will be followed for the duration of hospital stay
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An expected average of 3 weeks
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Length of ICU stays
大体时间：An expected average of 2 weeks
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Participant will be followed for the duration of ICU stay
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An expected average of 2 weeks
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Percentage of skeletal muscle mass
大体时间：Change from basline percentage skeletal muscle mass at day 43
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Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis
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Change from basline percentage skeletal muscle mass at day 43
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Correction vitamin D deficiency
大体时间：43 days
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Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo
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43 days
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合作者和调查者
调查人员
- 首席研究员：Daruneewan Warodomwichit、Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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