Vitamin D Supplementation for Foot and Ankle Surgery

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vitamin D supplements can aid recovery after foot or ankle surgery. The researchers aim to determine if vitamin D improves bone healing, enhances wound recovery, and reduces infection risk post-surgery. Participants will either receive vitamin D supplements (also known as Vitamin D3 or Cholecalciferol) or continue their usual care without additional vitamins. The trial seeks individuals undergoing surgery to fuse bones in their ankle or a toe joint. As an Early Phase 1 trial, this research focuses on understanding how vitamin D supplements function in people, offering participants a chance to contribute to groundbreaking knowledge in post-surgical recovery.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that vitamin D3 is generally safe and well-tolerated. Vitamin D plays a crucial role in maintaining bone health, and supplements can aid recovery from foot and ankle surgeries. Studies have found that taking vitamin D, either before or after surgery, can be beneficial without significant risk.

Vitamin D3 is widely used and accepted for its safety. However, it should be taken as directed, as excessive intake can cause problems, though this is rare when following prescribed doses. Overall, vitamin D3 supplements are considered safe and may support bone healing and prevent complications after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for foot and ankle surgery recovery focus on standard care practices like rest, physical therapy, and pain management. However, Vitamin D3 supplementation is unique because it aims to enhance bone healing and recovery by boosting vitamin D levels, which are crucial for bone health. Researchers are excited about this treatment because Vitamin D3 is a natural supplement that might improve surgical outcomes by strengthening bones and potentially speeding up recovery time. This approach offers a promising, non-invasive way to support patients post-surgery, which could complement existing care methods.

What evidence suggests that Vitamin D3 supplementation might be an effective treatment for bone healing after foot and ankle surgery?

Research shows that vitamin D is crucial for maintaining bone health and aiding in healing. Studies have found that adequate vitamin D intake can reduce the risk of fractures and improve healing. A deficiency in vitamin D may lead to slow bone healing and complications with wounds. Many individuals undergoing foot and ankle surgery have low vitamin D levels, potentially hindering their recovery. In this trial, participants in the Vitamin D Supplementation Group will receive 50,000 IU of Vitamin D3 weekly for 8 weeks, which may help by increasing levels and potentially improving recovery after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Rebecca Senehi, MD

Principal Investigator

Prisma Health-Midlands

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11047020/

Incidence of Vitamin D Deficiency in Foot and Ankle ... They found that 54 of 81 patients (67%) had hypovitaminosis D with only a 56% success rate for correcting the low vitamin D level after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8263860/

The role of vitamin D and vitamin D deficiency in ... Furthermore, a meta-analysis showed that optimising vitamin D intake reduced the incidence of non-vertebral fractures, while additional Calcium supplementation ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1268773117313681

Vitamin D levels in 577 consecutive elective foot & ankle ... Mean vitamin D levels were 52 nmol/L with a standard deviation of 28 in 577 consecutive foot and ankle surgery patients. · 1 in 5.7 patients had a level above 75 ...

4. acfas.org acfas.org/getattachment/c8333ff2-365f-4c2c-863c-1cb76f1bfba4/POST2018_SCI-1017.pdf?lang=en-US

Vitamin D Supplementation Protocol in Elective Arthrodesis ... Our study had 44% of patients with hypovitaminosis D, of which 15% qualified as deficient in vitamin D. These results are similar to those reported by Bogunovic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04772196

Temporal Profile of Serum Vitamin D Levels in Foot and ... Current retrospective studies suggest that having low vitamin D levels may lead to impaired fracture healing, increased wound complication rates, and a higher ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251623002788

Comparative Clinical Effects and Risk Factors Associated ... Based on our review, the current accepted vitamin D levels (≥20 ng/mL) are low and insufficient for fractures and for arthrodesis osseous healing.

7. orthopedic.theclinics.com orthopedic.theclinics.com/article/S0030-5898(18)30182-2/fulltext

Surgical Considerations for Vitamin D Deficiency in Foot ... Vitamin D repletion either preoperatively or postoperatively is a proposed way to optimize outcomes in orthopedic surgery, including foot and ...