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临床试验/EUCTR2017-001022-17-SE
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:
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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

发起方
Breastcentre, Capio St Gorans Hospital

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