Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Study Overview
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Brief Summary
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The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

Detailed Description
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The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Official Title
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A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: High Dose Vitamin D
* Dietary Supplement: Placebo
* Dietary Supplement: Standard Dose Vitamin D3
* Drug: Letrozole 2.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor Serum 25OHD levels < 40 ng/ml Exclusion Criteria: Severe or debilitating musculoskeletal pain Known metastatic disease History of renal stones History of hypercalcemia or hyperthyroidism Currently receiving adjuvant or neoadjuvant chemotherapy Currently receiving other investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Vitamin D<br>High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). | Dietary Supplement: High Dose Vitamin D<br>* High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.<br>Dietary Supplement: Standard Dose Vitamin D3<br>* Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)<br>Drug: Letrozole 2.5mg<br>* All subjects received letrozole as standard of care.<br>|
| Placebo Comparator: Placebo<br>Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). | Dietary Supplement: Placebo<br>* Placebo comparator<br>Dietary Supplement: Standard Dose Vitamin D3<br>* Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)<br>Drug: Letrozole 2.5mg<br>* All subjects received letrozole as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Worsening of Musculoskeletal Symptoms (MS) | Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms. | Change from Baseline to 24 Weeks |