Critical Illness Clinical Trial
Official title:
Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Medicine, Faculty of medicine, Ramathibodi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Length of hospital stays | Participant will be followed for the duration of hospital stay | An expected average of 3 weeks | No |
Secondary | Length of ICU stays | Participant will be followed for the duration of ICU stay | An expected average of 2 weeks | No |
Secondary | 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 | No |
Secondary | 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 | No |
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