A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
- •Serum 25OHD levels < 40 ng/ml
排除标准
- •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
研究组 & 干预措施
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).
干预措施: High Dose Vitamin D (Dietary Supplement)
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).
干预措施: Standard Dose Vitamin D3 (Dietary Supplement)
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).
干预措施: Letrozole 2.5mg (Drug)
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).
干预措施: Placebo (Dietary Supplement)
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).
干预措施: Standard Dose Vitamin D3 (Dietary Supplement)
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).
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
时间窗: Change from Baseline to 24 Weeks
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.
次要结局
未报告次要终点
研究者
Qamar Khan
Associate Professor
University of Kansas Medical Center