Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

Phase 3

• Conditions: Sarcopenia; Critical Illness; Vitamin D Deficiency
• Interventions: Drug: Vitamin D3; Drug: Placebo

• Registration Number: NCT02594579
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D3	Dietary Supplement: Vitamin D3
Placebo	Placebo	Dietary Supplement: Placebo

Primary Outcome Measures

Name	Time	Method
Rectus femoris cross-sectional diameer	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

Secondary Outcome Measures

Name	Time	Method
Correction vitamin D deficiency	43 days	Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo
Length of hospital stays	An expected average of 3 weeks	Participant will be followed for the duration of hospital stay
Length of ICU stays	An expected average of 2 weeks	Participant will be followed for the duration of ICU stay
Percentage of skeletal muscle mass	Change from basline percentage skeletal muscle mass at day 43	Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis

Trial Locations

Locations (1)

Department of Medicine, Faculty of medicine, Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand