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Vitamin

Vitamin D3 Supplementation for Joint Replacement Surgery

N/A

Recruiting

Led By Antonia F Chen, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients ≥18 years of age undergoing elective unilateral primary TJA for osteoarthritis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative visit to three months post-op

Awards & highlights

Study Summary

This trial will study whether giving Vitamin D before surgery can reduce postoperative complications.

Who is the study for?

This trial is for adults over 18 with hip or knee arthritis planning to have joint replacement surgery and have a Vitamin D level above 10 ng/mL. It's not for those with severe kidney disease, osteoporosis, hypercalcemia, hypocalcemia, granulomatous disease, hyperparathyroidism, pregnancy, previous infections in the joints or allergies to Vitamin D3.Check my eligibility

What is being tested?

The study tests if taking Vitamin D3 before surgery can lower the risk of complications after joint replacement. Participants will receive Vitamin D3 supplements to correct any deficiency before their operation.See study design

What are the potential side effects?

Vitamin D3 is generally safe but may cause mild side effects like nausea or skin reactions in rare cases (1 in 300). People with certain conditions like high calcium levels should avoid it due to potential serious side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult over 18 having joint replacement surgery for arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative visit to three months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative visit to three months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative visit to three months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Readmission, reoperation, wound complications, and PJI

Secondary outcome measures

Hip disability and Osteoarthritis Outcome Score (HOOS)

Pain Levels: visual analog scale (VAS)

Patient-Reported Outcomes Measurement Information System (PROMIS)

+1 more

Trial Design

3Treatment groups

Active Control

Group I: High Vitamin D3 SupplementationActive Control1 Intervention

Subjects enrolled into Group 2 (high-dose Vitamin D3 supplementation) will receive 50,000 IU of oral Vitamin D3 (Cholecalciferol) twice per week for 1 weeks followed by 50,000 IU once per week for 3 weeks prior to surgery. After surgery they will receive 50,000 IU of oral Vitamin D3 once per week for 4 weeks followed by 800 IU daily for 8 weeks. Vitamin D3 supplementation will be given for a total of 4 months.

Group II: No supplementationActive Control1 Intervention

Subjects with serum 25(OH)D level ≥30ng/mL will not receive any Vitamin D supplementation both pre- and postoperatively, as these are considered sufficient. These control patients will be asked to take any supplements containing Vitamin D for the duration of their participation in the trial. All patients in group 3 will have their serum 25(OH)D checked at 3 months after the surgery.

Group III: Low Vitamin D3 SupplementationActive Control1 Intervention

Subjects enrolled into Group 1 (low-dose Vitamin D3 supplementation) will receive 800 IU of oral Vitamin D3 (Cholecalciferol) daily for 4 weeks prior to surgery, followed by 800 IU of oral Vitamin D3 daily for 3 months after surgery. Vitamin D3 supplementation will be given for a total of 4 months. Supplementing Vitamin D-deficient patients with a minimum of 800 IU of Vitamin D3 daily is supported by the IOM.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,469,930 Total Patients Enrolled

4 Trials studying Vitamin D Deficiency

983 Patients Enrolled for Vitamin D Deficiency

Massachusetts General HospitalOTHER

2,933 Previous Clinical Trials

13,197,601 Total Patients Enrolled

10 Trials studying Vitamin D Deficiency

2,305 Patients Enrolled for Vitamin D Deficiency

Newton-Wellesley HospitalOTHER

12 Previous Clinical Trials

3,796 Total Patients Enrolled

Media Library

Vitamin D3 (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04229368 — N/A

Vitamin D Deficiency Research Study Groups: High Vitamin D3 Supplementation, No supplementation, Low Vitamin D3 Supplementation

Vitamin D Deficiency Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT04229368 — N/A

Vitamin D3 (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04229368 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment limit for this research project?

"Affirmative. The details posted on clinicaltrials.gov reveals that this experiment, which was published in September 2019, is recruiting patients for participation. A total of 900 individuals are needed to enroll at a single site."

Answered by AI

Is this research endeavor currently seeking participants?

"Per the information on clinicaltrials.gov, this experiment is currently searching for eligible participants. It was initially made available to the public on September 1st 2019 and has since been updated in March 2022."

Answered by AI

Recent research and studies

The Journal of Bone and Joint Surgery. British volumeJournal

Vitamin D Deficiency in Patients with Osteoarthritis Undergoing Total Hip Replacement

Nawabi, D. H., K. F. Chin, R. W. Keen, and F. S. Haddad. 2010. “Vitamin D Deficiency in Patients with Osteoarthritis Undergoing Total Hip Replacement”. The Journal of Bone and Joint Surgery. British Volume. British Editorial Society of Bone & Joint Surgery. doi:10.1302/0301-620x.92b3.23535.

Osteoporosis InternationalJournal

IOF Position Statement: Vitamin D Recommendations for Older Adults

Dawson-Hughes, B., A. Mithal, J.-P. Bonjour, S. Boonen, P. Burckhardt, G. E.-H. Fuleihan, R. G. Josse, P. Lips, J. Morales-Torres, and N. Yoshimura. 2010. “IOF Position Statement: Vitamin D Recommendations for Older Adults”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s00198-010-1285-3.

Journal of Vascular SurgeryJournal

Vitamin D Deficiency Is Associated with Mortality and Adverse Vascular Access Outcomes in Patients with End-stage Renal Disease

Walker, Joy P., Jade S. Hiramoto, Warren J. Gasper, Philip Auyang, Michael S. Conte, Joseph H. Rapp, David H. Lovett, and Christopher D. Owens. 2014. “Vitamin D Deficiency Is Associated with Mortality and Adverse Vascular Access Outcomes in Patients with End-stage Renal Disease”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2014.01.037.

Osteoporosis InternationalJournal