A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
研究概览
简要总结
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
详细描述
This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
- To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
- To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
- To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
- To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Observational Group
Patients with a baseline Vitamin D level below 10 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
干预措施: Vitamin D (Drug)
Observational Group
Patients with a baseline Vitamin D level below 10 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
干预措施: Calcium carbonate (Dietary Supplement)
Active Treatment Group
Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
干预措施: Vitamin D (Drug)
Active Treatment Group
Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
干预措施: Calcium carbonate (Dietary Supplement)
Control Group
Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 8 weeks and then once a month for a total of 6 months.
干预措施: Vitamin D (Drug)
Control Group
Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 8 weeks and then once a month for a total of 6 months.
干预措施: Calcium carbonate (Dietary Supplement)
Control Group
Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
- Calcium carbonate 1000 mg/day
- Vitamin D 400 units daily.
- Placebo once per week x 8 weeks and then once a month for a total of 6 months.
干预措施: Placebo (Other)
结局指标
主要结局
To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
时间窗: 6 months for randomized phase, 12 months for open-label phase
次要结局
- To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.(6 months for randomized phase, 12 months for open-label phase)
- To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.(6 months)
- To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.(6 months)