Vitamin D Deficiency Clinical Trial
Official title:
Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications
Vitamin D status has been shown to have an effect on post-operative outcomes in total joint arthroplasty. The goal of this study is to determine if pre-operative supplementation and correction of Vitamin D deficiency can reduce postoperative complications.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients =18 years of age undergoing elective unilateral primary TJA for osteoarthritis - Patients with a pre-operative serum 25(OH)D levels =10 ng/mL - Patients who consent to the study Exclusion Criteria: - Adult patients =18 years of age undergoing elective primary TJA with a pre-operative serum 25(OH)D2,3 level <10 ng/mL - Patients undergoing revision surgery - Patients lacking mental capacity to comply with study procedures - Patients with serum 25(OH)D levels between 10-29 ng/dL refusing to stop their current Vitamin D and multivitamins supplementations - Hypercalcemia (total calcium >10.6 mg/dL or ionized serum calcium >5.4mg/dL) - History of nephrolithiasis - Granulomatous disease - Dialysis and advanced kidney disease - Previous infection/septic arthritis - Inability to swallow Vitamin D3 pills - Allergy to Vitamin D3 (It is estimated that 1 in 300 individuals may have an allergy with skin manifestations 17) - Hypocalcemia (<8.5 mg/dL) - Chronic kidney disease (eGFR <60 mL/minute) - Known hyperparathyroidism - Known osteoporosis/insufficiency stress fractures (if normal stresses are applied to an abnormal bone) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Massachusetts General Hospital, Newton-Wellesley Hospital |
United States,
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Dawson-Hughes B, Mithal A, Bonjour JP, Boonen S, Burckhardt P, Fuleihan GE, Josse RG, Lips P, Morales-Torres J, Yoshimura N. IOF position statement: vitamin D recommendations for older adults. Osteoporos Int. 2010 Jul;21(7):1151-4. doi: 10.1007/s00198-010-1285-3. Epub 2010 Apr 27. — View Citation
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Heaney RP, Holick MF. Why the IOM recommendations for vitamin D are deficient. J Bone Miner Res. 2011 Mar;26(3):455-7. doi: 10.1002/jbmr.328. — View Citation
Hegde V, Dworsky EM, Stavrakis AI, Loftin AH, Zoller SD, Park HY, Richman S, Johansen D, Hu Y, Taylor JA, Hamad CD, Chun RF, Xi W, Adams JS, Bernthal NM. Single-Dose, Preoperative Vitamin-D Supplementation Decreases Infection in a Mouse Model of Periprosthetic Joint Infection. J Bone Joint Surg Am. 2017 Oct 18;99(20):1737-1744. doi: 10.2106/JBJS.16.01598. — View Citation
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View Citation
Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29. — View Citation
Iglar PJ, Hogan KJ. Vitamin D status and surgical outcomes: a systematic review. Patient Saf Surg. 2015 Apr 30;9:14. doi: 10.1186/s13037-015-0060-y. eCollection 2015. — View Citation
Jansen JA, Haddad FS. High prevalence of vitamin D deficiency in elderly patients with advanced osteoarthritis scheduled for total knee replacement associated with poorer preoperative functional state. Ann R Coll Surg Engl. 2013 Nov;95(8):569-72. doi: 10.1308/rcsann.2013.95.8.569. — View Citation
Lyles KW, Colon-Emeric CS, Magaziner JS, Adachi JD, Pieper CF, Mautalen C, Hyldstrup L, Recknor C, Nordsletten L, Moore KA, Lavecchia C, Zhang J, Mesenbrink P, Hodgson PK, Abrams K, Orloff JJ, Horowitz Z, Eriksen EF, Boonen S; HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007 Nov 1;357(18):1799-809. doi: 10.1056/NEJMoa074941. Epub 2007 Sep 17. — View Citation
Maier GS, Horas K, Seeger JB, Roth KE, Kurth AA, Maus U. Is there an association between periprosthetic joint infection and low vitamin D levels? Int Orthop. 2014 Jul;38(7):1499-504. doi: 10.1007/s00264-014-2338-6. Epub 2014 Apr 16. — View Citation
Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141. — View Citation
Nawabi DH, Chin KF, Keen RW, Haddad FS. Vitamin D deficiency in patients with osteoarthritis undergoing total hip replacement: a cause for concern? J Bone Joint Surg Br. 2010 Apr;92(4):496-9. doi: 10.1302/0301-620X.92B3.23535. — View Citation
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Taksler GB, Cutler DM, Giovannucci E, Keating NL. Vitamin D deficiency in minority populations. Public Health Nutr. 2015 Feb;18(3):379-91. doi: 10.1017/S1368980014000457. Epub 2014 Apr 15. — View Citation
Traven SA, Chiaramonti AM, Barfield WR, Kirkland PA, Demos HA, Schutte HD, Drew JM. Fewer Complications Following Revision Hip and Knee Arthroplasty in Patients With Normal Vitamin D Levels. J Arthroplasty. 2017 Sep;32(9S):S193-S196. doi: 10.1016/j.arth.2017.02.038. Epub 2017 Mar 8. — View Citation
Walker JP, Hiramoto JS, Gasper WJ, Auyang P, Conte MS, Rapp JH, Lovett DH, Owens CD. Vitamin D deficiency is associated with mortality and adverse vascular access outcomes in patients with end-stage renal disease. J Vasc Surg. 2014 Jul;60(1):176-83. doi: 10.1016/j.jvs.2014.01.037. Epub 2014 Feb 28. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Readmission, reoperation, wound complications, and PJI | adverse events | Preoperative visit to three months post-op | |
Secondary | Vitamin D status | Vitamin D levels will be drawn initially, during supplementation and following | Day of surgery to to three months post-op | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) | set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.41 to 78.3 with higher scores representing worse pain impact. | Preoperative visit to three months post-op | |
Secondary | Pain Levels: visual analog scale (VAS) | Scores on the VAS pain scale range from 0-10 with 0 being no pain and 10 being the highest pain level imaginable. | Preoperative visit to three months post-op | |
Secondary | Hip disability and Osteoarthritis Outcome Score (HOOS) | Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms | Preoperative visit to three months post-op |
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