Vitamin D Deficiency Clinical Trial
Official title:
A Pilot Study of Role of Vitamin D in Regulation of Bone Homeostasis in Orthopaedic Polytrauma Patients
Verified date | April 2019 |
Source | New York City Health and Hospitals Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 60 |
Est. completion date | March 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Males and females age 18-65 years 2. One or more orthopaedic injuries on admission 3. Admission injury severity score (ISS)=16 4. Anticipated stay in hospital of more than 7 days Exclusion Criteria: 1. Pregnancy (if patient becomes pregnant during the study, she will be removed from the study) 2. End stage kidney disease 3. Patients on furosemide, thiazide, or corticosteroid therapy 4. Patients with chronic liver disease 5. Patients with recent history of vitamin D supplementation more than 5000 IU/day 6. Patients actively undergoing chemo- or immunotherapy 7. Patients with hematologic and solid malignancies 8. Patients receiving treatment for osteoporosis 9. 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) |
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
New York City Health and Hospitals Corporation | Foundation of Orthopedic Trauma, Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Hospital length of stay | Patient hospital length of stay if patient leaves before hospital day 7 | 1 week | |
Secondary | In-hospital morbidity and mortality | Statistics regarding in-hospital morbidity and mortality | 1 week |
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