Vitamin D3 Supplementation for Joint Replacement Surgery

Recruiting in Palo Alto (17 mi)

Overseen byAntonia F Chen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing if taking Vitamin D3 supplements can reduce complications in patients with low Vitamin D levels undergoing joint replacement surgery. It aims to improve recovery by boosting Vitamin D levels and will evaluate the effectiveness of different doses of Vitamin D3.

Eligibility Criteria

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.

Inclusion Criteria

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

Patients with a pre-operative serum 25(OH)D levels ≥10 ng/mL

Patients who consent to the study

Exclusion Criteria

I am on dialysis or have advanced kidney disease.

My kidney function is reduced (eGFR <60 mL/min).

I have been diagnosed with hyperparathyroidism.

+13 more

Participant Groups

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.

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.

Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Cholecalciferol for: