Clinical trial NCT02295228: Hip Arthroplasty and Vitamin D Status
Official title: Hip Arthroplasty and Vitamin D Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Vitamin D, Vitamin D deficiency, Hip Arthroplasty
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 50+ undergoing elective total hip arthroplasty for osteoarthritis will be included. We will exclude individuals having these procedures for other conditions, e.g., rheumatoid arthritis, avascular necrosis and those undergoing reoperation of a previous hip arthroplasty.

Brief summary: It is essential that serum 25(OH)D changes following surgery be clarified, and the mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis of this study is that elective total hip arthroplasty reduces serum total 25(OH)D.


Eligibility criteria: Inclusion Criteria:

* Elective total hip arthroplasty for osteoarthritis
* Age 50+
* Able and willing to sign informed consent
* English speaking
* Willing to not alter vitamin D supplementation use for the duration of this study
* Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected

Exclusion Criteria:

* Illnesses known to affect inflammatory marker status including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis and mixed connective tissue disease
* Chronic diseases that could potentially affect DBP status, e.g., chronic kidney disease stage requiring dialysis, nephrotic syndrome and chronic hepatitis,
* Hip arthritis from causes other than osteoarthritis
* Treatment with medications with potential to affect vitamin D metabolism, (e.g., phenytoin, phenobarbital, teriparatide or active vitamin D analogues) or to potentially interfere with 25(OH)D measurement by HPLC (atavaquone) within the preceding three months.
* Treatment with high dose vitamin D supplementation (50,000 IU weekly or more frequently) within the preceding three months. Note; subjects on a stable daily vitamin D dose will be allowed to participate
* Surgical procedure within the preceding six months
* Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer

Primary outcomes:
measure: Change in total 25(OH)D
timeFrame: Measured at the pre-operative visit on the day of surgery, post-operative visit (on average 1 to 2 days after surgery), and 6 weeks post-operative visit
Secondary outcomes:
measure: DBP (vitamin D binding protein) in serum and urine will be evaluated for 25(OH)D degradation after surgical intervention.
timeFrame: Samples are collected at pre-operative visit on the day of surgery, post-operative (on average 1 to 2 days after surgery) and 6 weeks post-operative visits
measure: Effects of hip arthroplasty on vitamin D metabolite levels in the blood.
timeFrame: Samples are collected at pre-operative visit on the day of surgery, post-operative (on average 1 to 2 days after surgery) and 6 weeks post-operative visits
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil Binkley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: