Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-01-31

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.

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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,

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High Dose Vitamin D

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).

Group Type EXPERIMENTAL

High Dose Vitamin D

Intervention Type DIETARY_SUPPLEMENT

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

Standard Dose Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Letrozole 2.5mg

Intervention Type DRUG

All subjects received letrozole as standard of care.

Placebo

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator

Standard Dose Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Letrozole 2.5mg

Intervention Type DRUG

All subjects received letrozole as standard of care.

Interventions

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High Dose Vitamin D

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

Standard Dose Vitamin D3

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Intervention Type DIETARY_SUPPLEMENT

Letrozole 2.5mg

All subjects received letrozole as standard of care.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No