Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency

Conditions
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Vitamin D Deficiency, Sarcopenia, Critical Illness

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Dietary Supplement: Vitamin D3 | Drug: Vitamin D3<br>* 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<br>* Other names: Cholecalciferol (D3-50);|
| Placebo Comparator: Placebo<br>Dietary Supplement: Placebo | Drug: Placebo<br>* Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks<br>* Other names: Cholecalciferol (D3-50) placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectus femoris cross-sectional diameer | A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo | Change from baseline Rectus femoris cross-sectional diameter at day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stays | Participant will be followed for the duration of hospital stay | An expected average of 3 weeks | 
| Length of ICU stays | Participant will be followed for the duration of ICU stay | An expected average of 2 weeks | 
| Percentage of skeletal muscle mass | Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis | Change from basline percentage skeletal muscle mass at day 43 | 
| Correction vitamin D deficiency | Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo | 43 days |