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Hip Arthroplasty and Vitamin D Status

Hip Arthroplasty and Vitamin D Status

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02295228
Enrollment
43
Registered
2014-11-20
Start date
2015-01-31
Completion date
2015-11-30
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D, Vitamin D deficiency, 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.

Interventions

OTHERNo intervention

There are no interventions. This is an observational trial.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in total 25(OH)DMeasured 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

MeasureTime frameDescription
DBP (vitamin D binding protein) in serum and urine will be evaluated for 25(OH)D degradation after surgical intervention.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 visitsWe 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.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 visitsWe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026