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Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Sarcopenia Critical Illness Drug: Vitamin D3 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Cholecalciferol (D3-50) placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Length of hospital stays [ Time Frame: An expected average of 3 weeks ]
    Participant will be followed for the duration of hospital stay

  2. Length of ICU stays [ Time Frame: An expected average of 2 weeks ]
    Participant will be followed for the duration of ICU stay

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Daruneewan Warodomwichit (662)2011000 ext 0082 daruneewan@yahoo.com

Locations
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Thailand
Department of Medicine, Faculty of medicine, Ramathibodi Hospital
Bangkok, Thailand, 10400
Contact: Daruneewan Warodomwichit         
Principal Investigator: Daruneewan Warodomwichit, MD         
Sub-Investigator: Praopilad Srisuwarn, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Daruneewan Warodomwichit Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02594579    
Other Study ID Numbers: 075802
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Sarcopenia
Vitamin D Deficiency
Critical Illness
Disease Attributes
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents