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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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
Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
Department of Medicine, Faculty of medicine, Ramathibodi Hospital
Bangkok, Thailand
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
Time frame: Change from baseline Rectus femoris cross-sectional diameter at day 43
Length of hospital stays
Participant will be followed for the duration of hospital stay
Time frame: An expected average of 3 weeks
Length of ICU stays
Participant will be followed for the duration of ICU stay
Time frame: An expected average of 2 weeks
Percentage of skeletal muscle mass
Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis
Time frame: 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
Time frame: 43 days
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