What side effects are associated with this type of intervention?

Common treatments for Vitamin D deficiency, such as cholecalciferol (Vitamin D3) supplementation, are generally well-tolerated. However, potential side effects can include gastrointestinal upset, hypercalcemia (elevated calcium levels in the blood), and, in rare cases, kidney stones. High doses of Vitamin D3, especially when taken over a prolonged period, may increase the risk of these side effects. It is important to monitor serum calcium and Vitamin D levels during treatment to avoid toxicity.

What prior FDA approvals exist?

The FDA has approved several forms of Vitamin D for the treatment of Vitamin D deficiency, including cholecalciferol (Vitamin D3) and ergocalciferol (Vitamin D2). These treatments are typically administered in various dosages depending on the severity of the deficiency. High-dose cholecalciferol, such as 50,000 IU weekly, is commonly used for rapid repletion, while lower daily doses (e.g., 800-2000 IU) are used for maintenance. These treatments aim to correct deficiency and maintain adequate serum levels of 25-hydroxyvitamin D to support bone health and overall well-being.

What other types of research exist?

The provided context does not mention any specific novel alternatives to Vitamin D supplementation for correcting Vitamin D deficiency. Current treatments primarily focus on direct supplementation with Vitamin D3 (cholecalciferol) or Vitamin D2 (ergocalciferol). For patients considering treatment in 2024, it is advisable to continue with established Vitamin D supplementation protocols unless new research provides validated alternatives.

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Vitamin

Vitamin D3 Supplementation for Joint Replacement Surgery

Q: What is the mechanism of action of this treatment?

The most common treatments for Vitamin D deficiency include supplementation with vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol). These treatments work by increasing the levels of 25-hydroxyvitamin D in the blood, which is the main circulating form of vitamin D and a marker of vitamin D status. Vitamin D3 is generally preferred due to its higher potency and longer duration of action compared to vitamin D2. These supplements help improve calcium absorption in the gut, maintain adequate serum calcium and phosphate levels, and support bone mineralization. For patients with Vitamin D deficiency, these treatments are crucial as they help prevent bone disorders such as rickets in children and osteomalacia or osteoporosis in adults, thereby reducing the risk of fractures and improving overall musculoskeletal health.

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

Must not have

Dialysis and advanced kidney disease

Chronic kidney disease (eGFR <60 mL/minute)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative visit to three months post-op

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on dialysis or have advanced kidney disease.

Select...

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

Select...

I have been diagnosed with hyperparathyroidism.

Select...

I have had kidney stones in the past.

Select...

I am over 18 and have low vitamin D levels, planning for joint surgery.

Select...

I have been diagnosed with osteoporosis or stress fractures.

Select...

I am able to understand and follow the study's procedures.

Select...

My Vitamin D levels are low, but I won't stop taking my supplements.

Select...

I have a condition involving small areas of inflammation in my tissues.

Select...

I have had an infection or septic arthritis before.

Select...

I cannot swallow Vitamin D3 pills.

Select...

I am scheduled for a corrective surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Readmission, reoperation, wound complications, and PJI

Secondary study objectives

Hip disability and Osteoarthritis Outcome Score (HOOS)

Pain Levels: visual analog scale (VAS)

Patient-Reported Outcomes Measurement Information System (PROMIS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Vitamin D deficiency include supplementation with vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol). These treatments work by increasing the levels of 25-hydroxyvitamin D in the blood, which is the main circulating form of vitamin D and a marker of vitamin D status. Vitamin D3 is generally preferred due to its higher potency and longer duration of action compared to vitamin D2. These supplements help improve calcium absorption in the gut, maintain adequate serum calcium and phosphate levels, and support bone mineralization. For patients with Vitamin D deficiency, these treatments are crucial as they help prevent bone disorders such as rickets in children and osteomalacia or osteoporosis in adults, thereby reducing the risk of fractures and improving overall musculoskeletal health.

Musculoskeletal Pain and Vitamin D Deficiency in Children: A Pilot Follow-up Study of Vitamin D Therapy in Musculoskeletal/Orthopedic Conditions.