Clinical trial · Interventional
'Palliative-D' Vitamin D to Palliative Cancer Patients
'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
NCT03038516CI-TRIAL-00047104Palliative-DcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Drug | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vitamin D
- description
- Cholecalciferol (Detremin) solved in MIGLYOL® 812
- interventionNames
- Drug: Cholecalciferol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- MIGLYOL® 812
- interventionNames
- Device: Placebo
Primary outcomes (1)
- measure
- Change in opioid dose during 12 weeks
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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' Exclusion Criteria: 1. Ongoing vitamin D supplementation at the time for inclusion. 2. Serum level of 25-OH vitamin D3 \>50 nmol/L 3. Known sarkoidosis 4. Treatment with tiazides or digoxin or digitoxin 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. Hypersensitivity 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
References
Publications (2)
- DERIVEDGoodrose-Flores C, Bonn SE, Klasson C, Frankling MH, Lagerros YT, Bjorkhem-Bergman L. Appetite and its association with mortality in patients with advanced cancer - a Post-hoc Analysis from the Palliative D-study. BMC Palliat Care. 2023 Oct 26;22(1):159. doi: 10.1186/s12904-023-01287-1. PMID 37880704
- DERIVEDKlasson C, Helde-Frankling M, Sandberg C, Nordstrom M, Lundh-Hagelin C, Bjorkhem-Bergman L. Vitamin D and Fatigue in Palliative Cancer: A Cross-Sectional Study of Sex Difference in Baseline Data from the Palliative D Cohort. J Palliat Med. 2021 Mar;24(3):433-437. doi: 10.1089/jpm.2020.0283. Epub 2020 Sep 16. PMID 32936046