Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency Sarcopenia Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D

Dietary Supplement: Vitamin D3

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type 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

Placebo

Dietary Supplement: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cholecalciferol (D3-50) Cholecalciferol (D3-50) placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daruneewan Warodomwichit

Role: PRINCIPAL_INVESTIGATOR

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