Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2027-07-01

Brief Summary

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The purpose of this study is being conducted to determine whether correcting low levels of vitamin D with a single high-dose supplement reduces complications after the participant's primary TJA.

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Detailed Description

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Conditions

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Osteoarthritis Vitamin D Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Vitamin D Deficient Group

Participants who are vitamin D deficient and undergo standard of care TJA will receive a single dose of vitamin D. Total participation for up to 90 days.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Patients with a Vitamin D3 level of less than 30 nanograms per milliliter will receive a single oral (pill) dose of 300,000 international units of vitamin D3.

Interventions

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Vitamin D3

Patients with a Vitamin D3 level of less than 30 nanograms per milliliter will receive a single oral (pill) dose of 300,000 international units of vitamin D3.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Serum 25(OH)D \< 30 ng/mL within 2 weeks of surgery.
* Able to provide informed consent.

Exclusion Criteria

* Follow-up duration \< 90 days anticipated.
* Acute hepatitis, cancer, organ transplant recipients, or dialysis patients.
* Extra vitamin D supplementation within 90 days post-surgery.
* Preoperative serum 25(OH)D ≥ 30 ng/mL.
* Adults unable to consent (excluded).
* Individuals under 18 (excluded).
* Pregnant women (excluded).
* Prisoners (excluded).

Minimum Eligible Age

18 Years

Maximum Eligible Age

96 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No