Hip Arthroplasty and Vitamin D Status

NCT ID: NCT02295228

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-11-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No intervention

Intervention Type: OTHER

There are no interventions. This is an observational trial.

Interventions

No intervention

There are no interventions. This is an observational trial.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Binkley, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

2014-1025

Identifier Type: -

Identifier Source: org_study_id