Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02594579|
Recruitment Status : Unknown
Verified October 2015 by Mahidol University.
Recruitment status was: Not yet recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Sarcopenia Critical Illness||Drug: Vitamin D3 Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Vitamin D
Dietary Supplement: Vitamin D3
Drug: Vitamin 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
Other Name: Cholecalciferol (D3-50)
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
Other Name: Cholecalciferol (D3-50) placebo
- Rectus femoris cross-sectional diameer [ Time Frame: 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
- Length of hospital stays [ Time Frame: An expected average of 3 weeks ]Participant will be followed for the duration of hospital stay
- Length of ICU stays [ Time Frame: An expected average of 2 weeks ]Participant will be followed for the duration of ICU stay
- Percentage of skeletal muscle mass [ Time Frame: 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 [ Time Frame: 43 days ]Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594579
|Contact: Daruneewan Warodomwichit||(662)2011000 ext firstname.lastname@example.org|
|Department of Medicine, Faculty of medicine, Ramathibodi Hospital|
|Bangkok, Thailand, 10400|
|Contact: Daruneewan Warodomwichit|
|Principal Investigator: Daruneewan Warodomwichit, MD|
|Sub-Investigator: Praopilad Srisuwarn, MD|
|Principal Investigator:||Daruneewan Warodomwichit||Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand|