Vitamin D Supplementation for Foot and Ankle Surgery

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Prisma Health-Midlands

Disqualifiers: Active joint infection, prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Vitamin D3 for foot and ankle surgery?

Research suggests that having adequate Vitamin D levels may lead to better outcomes in foot and ankle surgeries, as Vitamin D is important for bone health and recovery. Patients with sufficient Vitamin D levels might experience fewer complications and better healing after surgery. ^{1 2 3 4 5}

Is Vitamin D supplementation safe for foot and ankle surgery patients?

Vitamin D supplementation is generally safe and well tolerated, with rare side effects, for patients undergoing foot and ankle surgery. ^{1 2 3 6 7}

How does vitamin D supplementation differ from other treatments for foot and ankle surgery?

Vitamin D supplementation is unique because it focuses on improving bone health and potentially enhancing healing after foot and ankle surgery, which is different from other treatments that may not address bone density or healing directly. This approach is particularly relevant for patients with lower bone mineral density, as indicated by studies using tibial Hounsfield unit measurements to predict healing outcomes. ^{8 9 10 11 12}

Research Team

Rebecca Senehi, MD

Principal Investigator

Prisma Health-Midlands

Eligibility Criteria

This trial is for adults over 18 who are having ankle or big toe joint fusion surgery and can communicate in English. It's not open to those under 18, with active joint infections, unable to consent, or prisoners.

Inclusion Criteria

I am 18 years old or older.

Subject speaks and understands English

I am having surgery to fuse bones in my ankle or big toe.

Exclusion Criteria

Subject is a prisoner

I am unable to give consent by myself.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or 50,000 IU Vitamin D3 weekly for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on post-surgical complications

6 months

Treatment Details

Interventions

• Vitamin D3

Trial Overview The study is testing if taking Vitamin D3 supplements helps improve bone healing, wound recovery, and prevent infections after foot-related fusion surgeries like ankle arthrodesis or metatarsophalangeal (big toe) joint arthrodesis.

Participant Groups

Group I: Vitamin D Supplementation Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Prisma Health-Midlands

Lead Sponsor

Trials

24

Recruited

2,800+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

References

1. France pubmed.ncbi.nlm.nih.gov

Vitamin D levels in 577 consecutive elective foot & ankle surgery patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical Considerations for Vitamin D Deficiency in Foot and Ankle Surgery. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

Vitamin D and foot and ankle trauma: An individual or societal problem. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Do 25-Hydroxyvitamin D Levels Correlate With Fracture Complications? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Vitamin D Deficiency and Outcomes After Ankle Fusion: A Short Report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Vitamin D Levels Do Not Predict Risk of Metatarsal Fractures. [2018]

7. Brazil pubmed.ncbi.nlm.nih.gov

Lower 25-hydroxyvitamin D (25OHD) levels, diabetes and age are associated with foot and ankle fracture treatment complications. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Responsiveness of the Manchester-Oxford Foot Questionnaire (MOXFQ) compared with AOFAS, SF-36 and EQ-5D assessments following foot or ankle surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Predicting Nonunions in Ankle Fractures Using Quantitative Tibial Hounsfield Samples From Preoperative Computed Tomography: A Multicenter Matched Case Control Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Reliability and validity of the subjective component of the American Orthopaedic Foot and Ankle Society clinical rating scales. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Danish Language Version of the American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHS) in Patients with Ankle-Related Fractures. [2021]

12. Poland pubmed.ncbi.nlm.nih.gov

Translation, Cultural Adaptation and Validation of Polish Version of Foot and Ankle Outcomes Questionnaire. [2019]