Clinical trial NCT02594579: Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient
Official title: Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vitamin D Deficiency
Sarcopenia
Critical Illness
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rectus femoris cross-sectional diameer
timeFrame: Change from baseline Rectus femoris cross-sectional diameter at day 43
Secondary outcomes:
measure: Length of hospital stays
timeFrame: An expected average of 3 weeks
measure: Length of ICU stays
timeFrame: An expected average of 2 weeks
measure: Percentage of skeletal muscle mass
timeFrame: Change from basline percentage skeletal muscle mass at day 43
measure: Correction vitamin D deficiency
timeFrame: 43 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of medicine, Ramathibodi Hospital
Study officials:
affiliation: Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand
name: Daruneewan Warodomwichit
role: PRINCIPAL_INVESTIGATOR
References: