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Vitamin D Supplementation for Foot and Ankle Surgery

Phase < 1
Waitlist Available
Led By Rebecca Senehi, MD
Research Sponsored by Prisma Health-Midlands
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is ≥ 18 years of age
Subject is undergoing ankle arthrodesis or MTP arthrodesis
Must not have
Subject is unable to provide consent
Subject is < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate whether vitamin D supplementation can improve outcomes for patients undergoing ankle or foot surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Vitamin D3 is generally safe but may cause side effects such as nausea, vomiting, constipation, weakness if taken in high doses. Most people do not experience severe side effects from standard doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am having surgery to fuse bones in my ankle or big toe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent by myself.
Select...
I am under 18 years old.
Select...
I currently have an infection in my joint.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-surgical complication rate following Vitamin D3 supplementation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin D Supplementation GroupExperimental Treatment1 Intervention
Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks.
Group II: Control GroupActive Control1 Intervention
Patients enrolled in the control group will receive standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590

Find a Location

Who is running the clinical trial?

Prisma Health-MidlandsLead Sponsor
23 Previous Clinical Trials
2,705 Total Patients Enrolled
Medical University of South CarolinaOTHER
972 Previous Clinical Trials
7,399,212 Total Patients Enrolled
Rebecca Senehi, MDPrincipal InvestigatorPrisma Health-Midlands

Media Library

Vitamin D3 Clinical Trial Eligibility Overview. Trial Name: NCT04772196 — Phase < 1
Ankle Fusion Research Study Groups: Control Group, Vitamin D Supplementation Group
Ankle Fusion Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT04772196 — Phase < 1
Vitamin D3 2023 Treatment Timeline for Medical Study. Trial Name: NCT04772196 — Phase < 1
~2 spots leftby Jan 2025
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