Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02594579
• Other study ID #: 075802
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 5, 2015
• Last updated: October 30, 2015
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Mahidol University
• Contact: Daruneewan Warodomwichit
• Phone: (662)2011000
• Email: daruneewan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Sarcopenia
• Vitamin D Deficiency

Intervention

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
• Placebo
Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of medicine, Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

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