Status:
WITHDRAWN
Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bio-Tech Pharmacal, Inc.
Conditions:
Hypovitaminosis D
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
In the United States, \~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents \~25,000 patien...
Eligibility Criteria
Inclusion
- Male or female
- Age ≥18 years
- English or Spanish speaking
- Scheduled for preoperative clinic assessment
- Scheduled to have elective hip or knee joint replacement surgery
- Not taking more than 1000 IU of either cholecalciferol or ergocalciferol daily
Exclusion
- Unable to provide consent
- Inability to comply with study protocol
- History of anemia (hematocrit \<25%)
- History of renal stones or hypercalcemia
- Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma)
- Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication)
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01858051
Start Date
January 1 2015
End Date
June 1 2017
Last Update
March 30 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114