Vitamin D DeficiencyPhase 2Palliative-DNCT03038516
'Palliative-D' Vitamin D to Palliative Cancer Patients
A Phase 2 study testing Cholecalciferol in people with Vitamin D Deficiency, run by Region Stockholm at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Nov 2017to 9 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
- 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.
- The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
- The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- 25 OHD < 50 nmol/L.
- Men and women aged ≥18
- Signed 'informed consent'
Who cannot join
- Ongoing vitamin D supplementation at the time for inclusion.
- Serum level of 25-OH vitamin D3 >50 nmol/L
- Known sarkoidosis
- Treatment with tiazides or digoxin or digitoxin
- Primary hyperparathyroidism
- Hypercalcaemia (verified by a laboratory result younger than 2 month)
Show all 12Show fewer
- Plans to leave the Stockholm county within 12 weeks of inclusion
- History of kidney stones
- Taking part of another clinical study involving drugs
- Hypersensitivity to cholecalciferol and/or any of the excipients
- Other criteria that could jeopardize the study or its intention as judged by the investigator
- Not being able to perform EORTC-QLQ-C15-PAL or ESAS
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
ASIH Stockholm Södra
Älvsjö, 12559
ASIH Stockholm Norr
Solna, Stockholm County, 171 54
Stockholms Sjukhem ASIH
Stockholm, 11219
About this study
Official title: 'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
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.
Read the detailed description
PROTOCOL IDENTITY AND OBJECTIVES: EudraCT Number 2017-000268-14 Protocol Title: Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial. Acronym: "Palliative-D" Trial Objectives: 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.
INVESTIGATIONAL MEDICINAL PRODUCTS (IMP): Test ProductDetremin, MA holder Renapharma; Pharmaceutical Form: Oil Route of Administration: Oral route
METHODOLOGY Trial Design: Double-blind, parallel randomised and placebo controlled trial Dose/Duration 4000 IU/day for 12 weeks
Primary Endpoint:
The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 3 measurements with 4 weeks intervals.
Secondary end Points:
- Decline in antibiotic consumption
- Improvement in quality of life
- Improvement in fatigue
- Vitamin D levels in serum after 12 weeks
- Association between opioid dose and genetic polymorphism in genes involved in the effect and metabolism of vitamin D in the body.
Efficacy Parameters:
Opioid dose, translated to fentanyl per hour measured at baseline and at week 4,8 and 12.
Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks. ESAS (Edmonton Symptom Assessment Scale ) measured at baseline and at week 4, 8 and 12.
Safety Parameters: S-calcium will be controlled in all subjects at baseline, at week 4, 8 and 12 and U-calcium in selected cases Power: The least clinically meaningful effect is estimated to be a 20% decline in opioid dose compared to the placebo. To obtain this result with 80% power the number of patients is estimated to be 127 in each arm i.e. 254 patients in total. This includes a drop-out of 25% per group.
Statistical Analyse plan: The primary endpoint will be analysed using linear regression, using bias corrected and accelerated bootstrap confidence intervals, while controlling for baseline measure of opioid dose (similar to ANCOVA). Adjustment for other background variables - such as vitamin D-level at baseline, gender and age - will be made in a secondary analysis to gain efficiency. The continuous secondary endpoints will be analysed using the same method as the primary endpoint .
POPULATION OF TRIAL SUBJECTS Number of Subjects: 254 (127 vitamin D and 127 placebo) Description of Trial Subjects: Palliative Cancer Patients (any cancer form) with a life expectancy of more than 3 months.
TRIAL TIMETABLE First Subject In Aug 2017 Last Subject In Sept 2019 (25 months to include participants) Last Subject Out Dec 2019 End of intervention Dec 2019 End of follow up Dec2019 End of Trial: Dec 2020
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol, Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Detremin
To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients is superior to placebo in decreasing opioid consumption, fatigue and infectious burden and increase quality of life.
PlaceboDevice
Also called MIGLYOL® 812
To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Cholecalciferol (Detremin) solved in MIGLYOL® 812 Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | MIGLYOL® 812 Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid dose during 12 weeks
The change in decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 4 measurements with 4 weeks intervals.
Measured: 12 weeks
Secondary outcomes (5)
Change in Antibiotic Consumption during 12 weeks
Change in Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
Measured: 12weeks
Change in Quality of life after 12 weeks
Change in Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.
Measured: 12 weeks
Change in Fatigue after12 weeks
Change in Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.
Measured: 12 weeks
Change in 25-hydroxyvitamin D levels after 12 weeks
Change in 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks.
Measured: 12 weeks
Change in Symptom burden during 12 weeks
Change in Symptom burden measured with ESAS (Edmonton Symptom Assessment Scale) at baseline and at week 4, 8 and 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Nov 2017
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Linda Björkhem-Bergman, Region Stockholm
- Investigators
- Linda Björkhem-Bergman, Assoc Prof, Principal investigator, Stockholm Läns Landsting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038516
- Sponsor's protocol ID
- Palliative-D
- Acronym
- Palliative-D
- Status last verified
- Sep 2020
- First submitted
- 17 Jan 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodrose-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.
PubMed 37880704Klasson 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.
PubMed 32936046
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03038516
- Acronym / sponsor ID
- Palliative-D / Palliative-D
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PROTOCOL IDENTITY AND OBJECTIVES: EudraCT Number 2017-000268-14 Protocol Title: Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial. Acronym: "Palliative-D" Trial Objectives: 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.
INVESTIGATIONAL MEDICINAL PRODUCTS (IMP): Test ProductDetremin, MA holder Renapharma; Pharmaceutical Form: Oil Route of Administration: Oral route
METHODOLOGY Trial Design: Double-blind, parallel randomised and placebo controlled trial Dose/Duration 4000 IU/day for 12 weeks
Primary Endpoint:
The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 3 measurements with 4 weeks intervals.
Secondary end Points:
- Decline in antibiotic consumption
- Improvement in quality of life
- Improvement in fatigue
- Vitamin D levels in serum after 12 weeks
- Association between opioid dose and genetic polymorphism in genes involved in the effect and metabolism of vitamin D in the body.
Efficacy Parameters:
Opioid dose, translated to fentanyl per hour measured at baseline and at week 4,8 and 12.
Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks. ESAS (Edmonton Symptom Assessment Scale ) measured at baseline and at week 4, 8 and 12.
Safety Parameters: S-calcium will be controlled in all subjects at baseline, at week 4, 8 and 12 and U-calcium in selected cases Power: The least clinically meaningful effect is estimated to be a 20% decline in opioid dose compared to the placebo. To obtain this result with 80% power the number of patients is estimated to be 127 in each arm i.e. 254 patients in total. This includes a drop-out of 25% per group.
Statistical Analyse plan: The primary endpoint will be analysed using linear regression, using bias corrected and accelerated bootstrap confidence intervals, while controlling for baseline measure of opioid dose (similar to ANCOVA). Adjustment for other background variables - such as vitamin D-level at baseline, gender and age - will be made in a secondary analysis to gain efficiency. The continuous secondary endpoints will be analysed using the same method as the primary endpoint .
POPULATION OF TRIAL SUBJECTS Number of Subjects: 254 (127 vitamin D and 127 placebo) Description of Trial Subjects: Palliative Cancer Patients (any cancer form) with a life expectancy of more than 3 months.
TRIAL TIMETABLE First Subject In Aug 2017 Last Subject In Sept 2019 (25 months to include participants) Last Subject Out Dec 2019 End of intervention Dec 2019 End of follow up Dec2019 End of Trial: Dec 2020
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: CholecalciferolCholecalciferol (Detremin) solved in MIGLYOL® 812 |
| Placebo | Placebo comparator | Device: PlaceboMIGLYOL® 812 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
- 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.
- The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
- The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- 25 OHD < 50 nmol/L.
Key exclusion criteria (12 listed)
- Ongoing vitamin D supplementation at the time for inclusion.
- Serum level of 25-OH vitamin D3 >50 nmol/L
- Known sarkoidosis
- Treatment with tiazides or digoxin or digitoxin
- Primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: DetreminTo test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients is superior to placebo in decreasing opioid consumption, fatigue and infectious burden and increase quality of life. | Drug | Vitamin D |
| PlaceboAlso: MIGLYOL® 812To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption, | Device | Placebo |
Primary outcome
Change in opioid dose during 12 weeks
Time frame: 12 weeks
The change in decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 4 measurements with 4 weeks intervals.
5 secondary outcomes
Change in Antibiotic Consumption during 12 weeks
Time frame: 12weeks
Change in Quality of life after 12 weeks
Time frame: 12 weeks
Change in Fatigue after12 weeks
Time frame: 12 weeks
Change in 25-hydroxyvitamin D levels after 12 weeks
Time frame: 12 weeks
Change in Symptom burden during 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 37880704Goodrose-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.
- Derived from this study: PubMed 32936046Klasson 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.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Björkhem-Bergman, Assoc Prof principal investigator
Stockholm Läns Landsting
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Vitamin D Deficiency, run by Region Stockholm at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid dose during 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.