Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications

NCT04229368 | Unknown

• 1 other identifier: 2018P001701
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy; Knee Arthropathy; Vitamin D Deficiency

Keywords

joint replacement; hip arthroplasty; knee arthroplasty; clinical outcomes; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Readmission, reoperation, wound complications, and PJI

  adverse events

  Preoperative visit to three months post-op

Secondary Outcomes (4)

• Vitamin D status

  Day of surgery to to three months post-op

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Preoperative visit to three months post-op

• Pain Levels: visual analog scale (VAS)

  Preoperative visit to three months post-op

• Hip disability and Osteoarthritis Outcome Score (HOOS)

  Preoperative visit to three months post-op

Study Arms (3)

Low Vitamin D3 Supplementation

ACTIVE COMPARATOR

Subjects enrolled into Group 1 (low-dose Vitamin D3 supplementation) will receive 800 IU of oral Vitamin D3 (Cholecalciferol) daily for 4 weeks prior to surgery, followed by 800 IU of oral Vitamin D3 daily for 3 months after surgery. Vitamin D3 supplementation will be given for a total of 4 months. Supplementing Vitamin D-deficient patients with a minimum of 800 IU of Vitamin D3 daily is supported by the IOM.

Dietary Supplement: Vitamin D3

High Vitamin D3 Supplementation

ACTIVE COMPARATOR

Subjects enrolled into Group 2 (high-dose Vitamin D3 supplementation) will receive 50,000 IU of oral Vitamin D3 (Cholecalciferol) twice per week for 1 weeks followed by 50,000 IU once per week for 3 weeks prior to surgery. After surgery they will receive 50,000 IU of oral Vitamin D3 once per week for 4 weeks followed by 800 IU daily for 8 weeks. Vitamin D3 supplementation will be given for a total of 4 months.

Dietary Supplement: Vitamin D3

No supplementation

NO INTERVENTION

Subjects with serum 25(OH)D level ≥30ng/mL will not receive any Vitamin D supplementation both pre- and postoperatively, as these are considered sufficient. These control patients will be asked to take any supplements containing Vitamin D for the duration of their participation in the trial. All patients in group 3 will have their serum 25(OH)D checked at 3 months after the surgery.

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D will be given at doses commonly given to patients with low vitamin D levels

Also known as: cholecalciferol

High Vitamin D3 Supplementation; Low Vitamin D3 Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator
• Newton-Wellesley Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 26333733 BACKGROUND

• 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.

  PMID: 20357324 BACKGROUND

• 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.

  PMID: 24165338 BACKGROUND

• Forrest KY, Stuhldreher WL. Prevalence and correlates of vitamin D deficiency in US adults. Nutr Res. 2011 Jan;31(1):48-54. doi: 10.1016/j.nutres.2010.12.001.

  PMID: 21310306 BACKGROUND

• 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.

  PMID: 25112179 BACKGROUND

• 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.

  PMID: 24737149 BACKGROUND

• 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.

  PMID: 28372917 BACKGROUND

• 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.

  PMID: 25926889 BACKGROUND

• 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.

  PMID: 24582700 BACKGROUND

• 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.

  PMID: 29040128 BACKGROUND

• Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.

  PMID: 25182228 BACKGROUND

• 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.

  PMID: 20422154 BACKGROUND

• 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.

  PMID: 21646368 BACKGROUND

• Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 Dietary Reference Intakes for Calcium and Vitamin D: what dietetics practitioners need to know. J Am Diet Assoc. 2011 Apr;111(4):524-7. doi: 10.1016/j.jada.2011.01.004.

  PMID: 21443983 BACKGROUND

• 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.

  PMID: 21337617 BACKGROUND

• 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.

  PMID: 15797954 BACKGROUND

• 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.

  PMID: 17878149 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Antonia F Chen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia F Chen, MD

CONTACT

617-525-5935; afchen@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 900 patients to be enrolled total including controls, and two additional study arms
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Arthroplasty Division, Principal Investigator

Model Details: Prospective randomized

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: September 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

US (1)