Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Vitamin D Deficiency; Sarcopenia
• Intervention / Treatment: Drug: Vitamin D3; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Department of Medicine, Faculty of medicine, Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Cholecalciferol (D3-50)
Placebo Comparator: Placebo; Dietary Supplement: Placebo	Drug: Placebo; Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks; Other Names: Cholecalciferol (D3-50) placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stays	Participant will be followed for the duration of hospital stay	An expected average of 3 weeks
Length of ICU stays	Participant will be followed for the duration of ICU stay	An expected average of 2 weeks
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
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Daruneewan Warodomwichit, Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Avitaminosis; Deficiency Diseases; Malnutrition; Muscular Atrophy; Atrophy; Vitamin D Deficiency; Sarcopenia; Critical Illness; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 075802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No