Vitamin D supplementation for patients with terminal cancer diagnosis - The patients will receive randomly either Vitamin D or inactive substance (placebo). Neither the patients or study personnel will know what treatment the patients will receive.

Phase 1

• Conditions: Any type of incurable cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000268-14-SE
• Lead Sponsor: ASIH Stockholm Södra, Långbro Park

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-20
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 254

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
F.1.2.1 Number of subjects for this age range 101
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153

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.
11. Other criteria that could jeopardize the study or its intention as judged by the investigator.
12. Not being able to perform EORTC-QLQ-C15-PAL or ESAS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified