Vitamin D3 for Aromatase Inhibitor Induced Arthralgias (VITAL)

Qamar Khan

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Letrozole 2.5mg; Dietary Supplement: Placebo; Dietary Supplement: High Dose Vitamin D; Dietary Supplement: Standard Dose Vitamin D3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00867217

11548

Details and patient eligibility

About

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.

Full description

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,

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

High Dose Vitamin D

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Standard Dose Vitamin D3

Dietary Supplement: High Dose Vitamin D

Drug: Letrozole 2.5mg

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Standard Dose Vitamin D3

Dietary Supplement: Placebo

Drug: Letrozole 2.5mg