Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

NCT02594579 | Unknown Phase 3 DMC

• 1 other identifier: 075802
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Sarcopenia; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of hospital stays

  An expected average of 3 weeks

• Length of ICU stays

  An expected average of 2 weeks

• Percentage of skeletal muscle mass

  Change from basline percentage skeletal muscle mass at day 43

• Correction vitamin D deficiency

  43 days

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D3

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Drug: Placebo

Interventions

Vitamin D3 DRUG

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

Also known as: Cholecalciferol (D3-50)

Vitamin D

Placebo DRUG

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

Also known as: Cholecalciferol (D3-50) placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 70 years old
• Expected ICU stay ≥ 48 hrs

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Medicine, Faculty of medicine, Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Sarcopenia; Critical Illness

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Daruneewan Warodomwichit

  Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daruneewan Warodomwichit

CONTACT

(662)2011000; daruneewan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: November 3, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

TH (1)