drugset / Trial / NCT04772196
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Phase 0
Active not recruiting
90 enrolled
Prisma Health-Midlands
Medical University of South Carolina · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively. This study will assess the effect of vitamin D supplementation on patient outcomes following ankle arthrodesis or first metatarsophalangeal joint arthrodesis.
Timeline
- Start
- 2020-12-21
- Primary completion
- 2026-12
- Completion
- 2026-12
Publications
- Background Bentli R, Taskapan H, Toktas H, Ulutas O, Ozkahraman A, Comert M. Significant independent predictors of vitamin d deficiency in inpatients and outpatients of a nephrology unit. Int J Endocrinol. 2013;2013:237869. doi: 10.1155/2013/237869. Epub 2013 May 12.
- Background Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
- Background Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.
- Background Lavernia CJ, Villa JM, Iacobelli DA, Rossi MD. Vitamin D insufficiency in patients with THA: prevalence and effects on outcome. Clin Orthop Relat Res. 2014 Feb;472(2):681-6. doi: 10.1007/s11999-013-3172-7.
- Background Somerson JS, Bartush KC, Shroff JB, Bhandari M, Zelle BA. Loss to follow-up in orthopaedic clinical trials: a systematic review. Int Orthop. 2016 Nov;40(11):2213-2219. doi: 10.1007/s00264-016-3212-5. Epub 2016 May 3.
- Background Zelle BA, Bhandari M, Sanchez AI, Probst C, Pape HC. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013 Mar;27(3):177-81. doi: 10.1097/BOT.0b013e31825cf367.
- Background Kristman V, Manno M, Cote P. Loss to follow-up in cohort studies: how much is too much? Eur J Epidemiol. 2004;19(8):751-60. doi: 10.1023/b:ejep.0000036568.02655.f8.
- Background Nwankwo EC Jr, Labaran LA, Athas V, Olson S, Adams SB. Pathogenesis of Posttraumatic Osteoarthritis of the Ankle. Orthop Clin North Am. 2019 Oct;50(4):529-537. doi: 10.1016/j.ocl.2019.05.008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 50000 iu | — |
Indications
No indication recorded.