Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rectus femoris cross-sectional diameer
研究概览
简要总结
A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition.
详细描述
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years old
- •Expected ICU stay ≥ 48 hrs
排除标准
- •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
研究组 & 干预措施
Vitamin D
Dietary Supplement: Vitamin D3
干预措施: Vitamin D3 (Drug)
Placebo
Dietary Supplement: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rectus femoris cross-sectional diameer
时间窗: Change from baseline Rectus femoris cross-sectional diameter at day 43
A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo
次要结局
- Correction vitamin D deficiency(43 days)
- Length of hospital stays(An expected average of 3 weeks)
- Length of ICU stays(An expected average of 2 weeks)
- Percentage of skeletal muscle mass(Change from basline percentage skeletal muscle mass at day 43)