Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery

NCT04772196 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Pro00095065
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

MTP Arthrodesis; Ankle Arthrodesis

Outcome Measures

Primary Outcomes (1)

• Post-surgical complication rate following Vitamin D3 supplementation

  Patients will be followed for 6 months post-operatively to determine overall complication rate in patients receiving Vitamin D3 supplementation vs. standard of care. Complications will include infection, wound healing complications, readmission, re-operation, and clinical or radiographic nonunion.

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

Patients enrolled in the control group will receive standard of care.

Vitamin D Supplementation Group

EXPERIMENTAL

Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

50,000 IU Vitamin D3 weekly for 8 weeks

Vitamin D Supplementation Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years of age
• Subject is undergoing ankle arthrodesis or MTP arthrodesis
• Subject speaks and understands English

You may not qualify if:

• Subject is \< 18 years of age
• Subject has an active joint infection
• Subject is unable to provide consent
• Subject is a prisoner

Sponsors & Collaborators

• Prisma Health-Midlands: lead
• Medical University of South Carolina: collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Related Publications (8)

• 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.

  PMID: 23737771 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.

  PMID: 20926724 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.

  PMID: 20511058 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.

  PMID: 23868422 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.

  PMID: 27142421 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.

  PMID: 23449099 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.

  PMID: 15469032 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.

  PMID: 31466668 BACKGROUND

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive either standard of care or supplemental Vitamin D3 following total ankle arthroplasty, ankle arthrodesis, or first metatarsophalangeal joint arthrodesis.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: December 21, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)