Hip Arthroplasty and Vitamin D Status

NCT02295228 | Completed

• 1 other identifier: 2014-1025
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Keywords

Vitamin D, Vitamin D deficiency, Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 visits

• 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 visits

Study Arms (1)

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

Interventions

No intervention OTHER

There are no interventions. This is an observational trial.

Adults undergoing total hip arthroplasty

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples will be collected at all time points. Blood and urine aliquots will also be banked from each visit.

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Neil Binkley, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 11, 2018

Record last verified: 2018-06