Evaluating Vitamin D3 Supplement on Post-Op Outcomes

NCT04177758 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19092704
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if vitamin D supplementation is associated with differences in short-term recovery in patients following total knee arthroplasty compared to patients who do not receive supplementation. If so, vitamin D supplementation has the potential to become widely incorporated into the routine care for patients undergoing knee replacements.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative

  The functional component of the 2012 version of the knee society score at 3 weeks following surgery. Range 0-100. Assessed at 3 weeks following surgery, 3 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.

  Assessed at 3 weeks following surgery

• Knee Society Score (KSS) at 6 Weeks Following Surgery

  The functional component of the 2012 version of the knee society score at 6 weeks following surgery. Range 0-100. Assessed at 6 weeks following surgery, 6 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.

  Assessed at 6 weeks following surgery reported

Secondary Outcomes (3)

• Timed up and go Test at 3 Weeks Post Surgery

  Assessed at 3 weeks following surgery

• Timed up and go Test Difference From Baseline to 6 Weeks After Surgery

  value at 6 weeks minus value at baseline

• Number of Participants With Complications

  6 weeks following surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm.

Drug: Control

Treatment

EXPERIMENTAL

Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.

Drug: Vitamin D

Interventions

Vitamin D DRUG

Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.

Treatment

Control DRUG

Patients randomized to the control will receive a placebo

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing primary total knee arthroplasty for osteoarthritis
• Age ≥ 18 years old
• Willingness to undergo randomization and return for all scheduled visits

You may not qualify if:

• Age \> 80 years old
• American Society of Anesthesiologists (ASA) Score ≥ 4
• Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
• Current cancer
• Malabsorption syndromes
• Inability to take medications orally
• Renal impairment defined as a glomerular filtration rate (GFR) \< 30 mL/minute or creatinine \>1.3 mg/dL
• History of hypercalcemia defined as albumin-corrected hypercalcemia \>12 mg/dL

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The dosing regimen included a one-time dose of 50,000IU vitamin D3, which may not be large enough to identify clinically significant differences. A higher than anticipated drop-out rate in this study occurred. Additionally, patients already taking vitamin D supplements were excluded from participation. We did not test patients for vitamin D deficiency preoperatively. We were unable to conduct a cost-analysis to support the cost-effectiveness of nonselective treatment.

Results Point of Contact

• Title: Anne DeBenedetti, MSc
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

312-432-2468

Study Officials

• Denis Nam, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgery

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: February 1, 2020
• Primary Completion: October 8, 2021
• Study Completion: March 1, 2022
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)