## Protocol Section
### Identification Module
**NCT ID:** NCT02594579

**Brief Title:** Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

**Official Title:** Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency

#### Organization Study ID Info
**ID:** 075802
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2015-11-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-10

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2015-11-03
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-05
**Study First Submit QC Date:** 2015-10-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mahidol University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Vitamin D Deficiency

- Sarcopenia

- Critical Illness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dietary Supplement: Vitamin D3

**Intervention Names:**

- Drug: Vitamin D3

**Label:** Vitamin D

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Dietary Supplement: Placebo

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vitamin D

**Description:** 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

**Name:** Vitamin D3

**Other Names:**

- Cholecalciferol (D3-50)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

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

**Name:** Placebo

**Other Names:**

- Cholecalciferol (D3-50) placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo

**Measure:** Rectus femoris cross-sectional diameer

**Time Frame:** Change from baseline Rectus femoris cross-sectional diameter at day 43

#### Secondary Outcomes

**Description:** Participant will be followed for the duration of hospital stay

**Measure:** Length of hospital stays

**Time Frame:** An expected average of 3 weeks

**Description:** Participant will be followed for the duration of ICU stay

**Measure:** Length of ICU stays

**Time Frame:** An expected average of 2 weeks

**Description:** Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis

**Measure:** Percentage of skeletal muscle mass

**Time Frame:** Change from basline percentage skeletal muscle mass at day 43

**Description:** Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo

**Measure:** Correction vitamin D deficiency

**Time Frame:** 43 days

### Eligibility Module

**Eligibility 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** daruneewan@yahoo.com

**Name:** Daruneewan Warodomwichit

**Phone:** (662)2011000

**Phone Ext:** 0082

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bangkok

**Contacts:**

***Contact 1:***

- **Name:** Daruneewan Warodomwichit

- **Role:** CONTACT

***Contact 2:***

- **Name:** Daruneewan Warodomwichit, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Praopilad Srisuwarn, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Thailand

**Facility:** Department of Medicine, Faculty of medicine, Ramathibodi Hospital

**Zip:** 10400

#### Overall Officials

**Official 1:**

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

**Name:** Daruneewan Warodomwichit

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009133

- Term: Muscular Atrophy

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001284

- Term: Atrophy

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001361

- Term: Avitaminosis

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M28396

- Name: Sarcopenia

- Relevance: HIGH

- As Found: Sarcopenia

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Vitamin D Deficiency

- ID: M12090

- Name: Muscular Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4660

- Name: Avitaminosis

- Relevance: LOW

- As Found: Unknown

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055948

- Term: Sarcopenia

- ID: D000014808

- Term: Vitamin D Deficiency

- ID: D000016638

- Term: Critical Illness

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: HIGH

- As Found: 2.5

- ID: M6003

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: 2.5

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: 2.5

- ID: T479

- Name: Vitamin D3

- Relevance: HIGH

- As Found: 2.5

- ID: T440

- Name: Calciferol

- Relevance: HIGH

- As Found: 2.5

### Intervention Browse Module - Meshes

- ID: D000014807

- Term: Vitamin D

- ID: D000002762

- Term: Cholecalciferol

### Misc Info Module

- Version Holder: 2024-05-24
