Hip Arthroplasty and Vitamin D Status
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|ClinicalTrials.gov Identifier: NCT02295228|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment|
|Vitamin D Deficiency||Other: No intervention|
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Hip Arthroplasty and Vitamin D Status|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Adults undergoing total hip arthroplasty
No intervention will be administered, this is an observational trial. The study population includes adults 50+ who are undergoing elective total hip arthroplasty for osteoarthritis.
Other: No intervention
There are no interventions. This is an observational trial.
- Change in total 25(OH)D [ Time Frame: 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 ]
- DBP (vitamin D binding protein) in serum and urine will be evaluated for 25(OH)D degradation after surgical intervention. [ Time Frame: 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 ]We will evaluate if free 25(OH)D varies over the peri-operative time period. We will evaluate whether the total 25(OH)D change is related to reduced serum DBP and/or increased urinary DBP excretion. We will also correlate the change in free 25(OH)D with serum DBP changes.
- Effects of hip arthroplasty on vitamin D metabolite levels in the blood. [ Time Frame: 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 ]We will evaluate the acute and chronic effects of hip arthroplasty on vitamin D metabolites, vitamin D pathway constituents, inflammation, oxidative stress and metabolic markers in plasma using mass spectrometric proteomic and metabolomics analysis.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295228
|Principal Investigator:||Neil Binkley, M.D.||University of Wisconsin, Madison|