EUCTR2017-000268-14-SE
Active, not recruiting
Phase 1
Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial - Palliative-D
ASIH Stockholm Södra, Långbro Park0 sites254 target enrollmentMarch 20, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Any type of incurable cancer
- Sponsor
- ASIH Stockholm Södra, Långbro Park
- Enrollment
- 254
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
- •2\. Incurable cancer patients with any type of cancer. They could have ongoing oncological treatment but only with palliative intention. No patients with ongoing oncological treatment with curative intended treated will be included.
- •3\. The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
- •4\. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- •5\. 25 OHD \< 50 nmol/L.
- •6\. Men and women aged \=18\.
- •7\. 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
Exclusion Criteria
- •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 tiazides.
- •5\. Primary hyperparathyroidism.
- •6\. Hypercalcaemia (verified by a laboratory result younger than 2 month).
- •7\. Plans to leave the Stockholm county within 12 weeks of inclusion.
- •8\. History of kidney stones.
- •9\. Taking part of another clinical study involving drugs.
- •10\. Hypersensivity to cholecalciferol and/or any of the excipients.
Outcomes
Primary Outcomes
Not specified
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