Critical Illness, Sarcopenia, Vitamin D Deficiency
Conditions
Brief summary
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
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.
Interventions
DRUGVitamin D3
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
DRUGPlacebo
Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectus femoris cross-sectional diameer | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stays | An expected average of 3 weeks | Participant will be followed for the duration of hospital stay |
| Length of ICU stays | An expected average of 2 weeks | Participant will be followed for the duration of ICU stay |
| Percentage of skeletal muscle mass | Change from basline percentage skeletal muscle mass at day 43 | Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis |
| Correction vitamin D deficiency | 43 days | Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo |
Countries
Thailand
Contacts
Primary ContactDaruneewan Warodomwichit
Outcome results
None listed