Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
Primary Purpose
Vitamin D Deficiency, Polytrauma, Orthopedic Disorder
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]
Propylene Glycol
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Deficiency, Insufficiency, Bone turnover, Bone healing, Polytrauma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Jacobi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Vitamin D control
Vitamin D intervention cohort
Arm Description
The control cohort will receive 50cc of propylene glycol as placebo via oral, nasogastric tube, or gastrostomy route on hospital admission.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Hospital length of stay
Patient hospital length of stay if patient leaves before hospital day 7
In-hospital morbidity and mortality
Statistics regarding in-hospital morbidity and mortality
Full Information
NCT ID
NCT03066817
First Posted
February 23, 2017
Last Updated
April 2, 2019
Sponsor
New York City Health and Hospitals Corporation
Collaborators
Foundation of Orthopedic Trauma, Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03066817
Brief Title
Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
Official Title
A Pilot Study of Role of Vitamin D in Regulation of Bone Homeostasis in Orthopaedic Polytrauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Suspended
Why Stopped
Waiting for annual IRB progress report to be reviewed and approved
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York City Health and Hospitals Corporation
Collaborators
Foundation of Orthopedic Trauma, Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Sixty polytrauma patients presenting to Jacobi Medical Center will be screened for eligibility according to strict inclusion and exclusion criteria by study personnel on admission. Medical history, physical examination, and laboratory findings will be collected and assessed to ensure that patients meet the inclusion and exclusion criteria. Eligible subjects will be enrolled after obtaining informed consent from either the subject or health care proxy if the subject is not able to participate in the decision-making process secondary to his injuries or mental status. As this dose of vitamin D has not been previously studied in pregnant subjects, female subjects will be counseled on potential pregnancy risks and will undergo urine pregnancy testing prior to administration of the investigational agent/placebo. Female patients testing positive for pregnancy will be removed from the study. Upon enrollment, study personnel will assign subjects a study ID and record this information in a password-protected data collection document.
All enrolled subjects will have blood draws by phlebotomy or nursing staff for the above-mentioned bone turnover markers once consent is obtained. This will include specimen collection and processing for the following serum levels in both study arms: 25(OH)-D, PTH, collagen type I C-telopeptide, calcium, phosphorus, osteocalcin, and alkaline phosphatase. This initial specimen collection will occur in the interval between 0 and 72 hours of hospital admission.
Collected specimen will be assigned unique identifiers corresponding to patients' study IDs and delivered to core labs at Jacobi Medical Center. From there, the specimen will be sent to an outside testing facility (Northwell Laboratories, Lake Success, NY), where specimen processing will occur. Normal laboratory values will be established by the outside testing facility according to CLIA standards.
The study personnel will liaise with the JMC Main or Satellite Pharmacy to alert them regarding newly enrolled study subjects. The pharmacist will then assign patients according to randomization algorithm in a 1:1 ratio to intervention and control arms, with 30 patients in each group by the end of the study accrual. The pharmacist will then prepare and transport the investigational agent or placebo to the subject's location for administration by nursing staff.
The intervention cohort will receive 400,000IU liquid ergocalciferol (50cc of 8000IU/cc Calcidol solution) via oral, NG tube, or gastrostomy route.
The control cohort will receive 50cc of propylene glycol as placebo via oral, NG tube, or gastrostomy route.
A repeat specimen collection of above-mentioned bone turnover markers will commence either at 7 days if patient is still inpatient, or at discharge, whichever occurs first. The specimens obtained at that time will be treated in the same manner as the initial specimens.
For each enrolled subject, the investigators will collect data from hospital presentation to discharge on standard demographics, routine laboratory results, clinical and injury characteristics and hospital course data (length of stay, in-hospital mortality, mobilization status, associated inpatient procedures and complications).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Polytrauma, Orthopedic Disorder
Keywords
Vitamin D, Deficiency, Insufficiency, Bone turnover, Bone healing, Polytrauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D control
Arm Type
Placebo Comparator
Arm Description
The control cohort will receive 50cc of propylene glycol as placebo via oral, nasogastric tube, or gastrostomy route on hospital admission.
Arm Title
Vitamin D intervention cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]
Other Intervention Name(s)
Calcidol
Intervention Description
50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose.
Intervention Type
Drug
Intervention Name(s)
Propylene Glycol
Intervention Description
50cc of propylene glycole will be given to participants as one-time dose, used as placebo
Primary Outcome Measure Information:
Title
25(OH)-D serum level in relation to other serum markers of bone turnover
Description
Serum Vitamin D Level, Serum Parathyroid Hormone Level, Serum C-terminal Telopeptide Level, Serum Osteocalcin Level
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
Patient hospital length of stay if patient leaves before hospital day 7
Time Frame
1 week
Title
In-hospital morbidity and mortality
Description
Statistics regarding in-hospital morbidity and mortality
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Sen, MD
Organizational Affiliation
Montefiore Medical Center / Jacobi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data are not planned to be shared.
Learn more about this trial
Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
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