EUCTR2017-001022-17-SE进行中(未招募)1 期
Vitamin D supplementation to breast cancer patients with adjuvant endocrine treatment – An observational clinical study where the patient is its own control. - VIDE
Breastcentre, Capio St Gorans Hospital0 个研究点开始时间: 2017年3月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Breast cancer survivors at the Breastcentre, St Gorans Hospital on adjuvant endocrine treatment with an aromatase inhibitor having joint pain
- •2. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- •3. 25 OHD < 50 nmol/L.
- •4. Women aged =18.
- •5. Signed 'informed consent'.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Ongoing vitamin D or calcium supplementation at the time for inclusion.
- •2. Serum level of 25-OH vitamin D3 >/= 50 nmol/L.
- •3. Known sarkoidosis.
- •4. Treament with tizzies.
- •5. Primary hyperparathyroidism.
- •6. Hypercalcaemia (verified by a laboratory result younger than 2 month).
- •7. History of kidney stones.
- •8. Hypersensivity to cholecalciferol and/or any of the excipients.
- •9. Other criteria that could jeopardize the study or its intention as judged by the investigator.
- •10. Not being able to perform EORTC-QLQ-BR23 or Brief Pain Inventory Short Form.
研究者
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