Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients

NCT03066817 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: MSMB01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Although vitamin D is known to play a major role in multiple organ functions in healthy adults, including bone homeostasis, its role in the unique population of orthopaedic polytrauma patients has not been well described. The aim of this therapeutic randomized placebo-controlled feasibility study is to determine the effect of vitamin D supplementation initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for all the patients on admission, and the intervention arm will receive a one-time dose of ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7 days after the initial draw or at discharge, whichever occurs first. Patients' daily immobilization status, baseline characteristics and clinical outcomes will be recorded. Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone turnover markers levels associated with the intervention.

Conditions

Vitamin D Deficiency; Polytrauma; Orthopedic Disorder

Keywords

Vitamin D; Deficiency; Insufficiency; Bone turnover; Bone healing; Polytrauma

Outcome Measures

Primary Outcomes (1)

• 25(OH)-D serum level in relation to other serum markers of bone turnover

  Serum Vitamin D Level, Serum Parathyroid Hormone Level, Serum C-terminal Telopeptide Level, Serum Osteocalcin Level

  1 week

Secondary Outcomes (2)

• Hospital length of stay

  1 week

• In-hospital morbidity and mortality

  1 week

Study Arms (2)

Vitamin D control

PLACEBO COMPARATOR

The control cohort will receive 50cc of propylene glycol as placebo via oral, nasogastric tube, or gastrostomy route on hospital admission.

Drug: Propylene Glycol

Vitamin D intervention cohort

EXPERIMENTAL

The intervention cohort will receive a one-time 400,000 IU liquid ergocalciferol (50cc of Ergocalciferol 8000 IU/ML Oral Liquid \[DRISDOL\]) via oral, nasogastric tube, or gastrostomy route on hospital admission.

Drug: Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]

Interventions

Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL] DRUG

50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose.

Also known as: Calcidol

Vitamin D intervention cohort

Propylene Glycol DRUG

50cc of propylene glycole will be given to participants as one-time dose, used as placebo

Vitamin D control

Eligibility Criteria

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

You may qualify if:

• Males and females age 18-65 years
• One or more orthopaedic injuries on admission
• Admission injury severity score (ISS)≥16
• Anticipated stay in hospital of more than 7 days

You may not qualify if:

• Pregnancy (if patient becomes pregnant during the study, she will be removed from the study)
• End stage kidney disease
• Patients on furosemide, thiazide, or corticosteroid therapy
• Patients with chronic liver disease
• Patients with recent history of vitamin D supplementation more than 5000 IU/day
• Patients actively undergoing chemo- or immunotherapy
• Patients with hematologic and solid malignancies
• Patients receiving treatment for osteoporosis
• Patients with "nothing per mouth" status secondary to any preceding procedures involving their GI system (e.g. patients with colectomy performed on this admission secondary to gunshot wound to abdomen)

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead
• Foundation of Orthopedic Trauma: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Multiple Trauma; Musculoskeletal Diseases

Interventions

Ergocalciferols; Fluid Therapy; Propylene Glycol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Drug Therapy; Therapeutics; Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Milan Sen, MD

  Montefiore Medical Center / Jacobi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: July 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)