Hip Arthroplasty and Vitamin D Status

Vitamin D Deficiency Clinical Trial

Official title:

Hip Arthroplasty and Vitamin D Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295228
• Other study ID #: 2014-1025
• Status: Completed
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: June 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• No intervention
There are no interventions. This is an observational trial.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total 25(OH)D		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	DBP (vitamin D binding protein) in serum and urine will be evaluated for 25(OH)D degradation after surgical intervention.	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.	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
Secondary	Effects of hip arthroplasty on vitamin D metabolite levels in the blood.	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.	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