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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I am having surgery to fuse bones in my ankle or big toe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-surgical complication rate following Vitamin D3 supplementation
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
2,736 Total Patients Enrolled
Medical University of South CarolinaOTHER
936 Previous Clinical Trials
7,396,748 Total Patients Enrolled
Rebecca Senehi, MDPrincipal InvestigatorPrisma Health-Midlands
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am unable to give consent by myself.I am under 18 years old.I currently have an infection in my joint.I am having surgery to fuse bones in my ankle or big toe.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Vitamin D Supplementation Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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