Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hip Arthroplasty and Vitamin D Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02295228
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Other: No intervention

Layout table for study information
Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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
Blood and urine samples will be collected at all time points. Blood and urine aliquots will also be banked from each visit.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Neil Binkley, M.D. University of Wisconsin, Madison

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02295228     History of Changes
Other Study ID Numbers: 2014-1025
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Keywords provided by University of Wisconsin, Madison:
Vitamin D, Vitamin D deficiency, Hip Arthroplasty

Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents