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.

Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial - Palliative-D

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000268-14-SE

Enrollment

254

Registered

2017-03-20

Start date

2017-05-15

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any type of incurable cancer

Interventions

Trade Name: Detremin Pharmaceutical Form: Oral drops, solution INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: CHOLECALCIFEROL CONCENTRATE Concentration unit: mg/ml milligram(s)/millilitr

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 153

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to test the hypothesis vitamin D supplementation for 12 weeks reduces opioid consumption.;Secondary Objective: The secondary objectives are to test the hypothesis that vitamin D supplementation for 12 weeks leads to decline in antibiotic consumption, improvement in quality of life and improvement in fatigue. The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied. We will also investigate the change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897). The safety objective is to verify that the use of vitamin D is safe and tolerable. ;Primary end point(s): 1) The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo groups, based on 4 measurements with 4 week intervals.;Timepoint(s) of evaluation of this end point: 1) Opioid dose, translated to fentanyl per hour measured at baseline and at week 4, 8 and 12.	—

Measure

Time frame

Main Objective: The primary objective is to test the hypothesis vitamin D supplementation for 12 weeks reduces opioid consumption.;Secondary Objective: The secondary objectives are to test the hypothesis that vitamin D supplementation for 12 weeks leads to decline in antibiotic consumption, improvement in quality of life and improvement in fatigue. The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied. We will also investigate the change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897). The safety objective is to verify that the use of vitamin D is safe and tolerable. ;Primary end point(s): 1) The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo groups, based on 4 measurements with 4 week intervals.;Timepoint(s) of evaluation of this end point: 1) Opioid dose, translated to fentanyl per hour measured at baseline and at week 4, 8 and 12.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Decline in antibiotic consumption (expressed as % of days with antibiotics during the last 4 weeks) based on measurements at baseline, week 4, 8 and 12. 2) Improvement in quality of life measured with EORTC-QLQ-PAL15 at screening and after 12 weeks 3) Improvement in fatigue measured with EORTC-QLQ-PAL15 at screening and after 12 weeks 4) Improvement in symptom burden measured with ESAS. 5) Levels of 25-OHD in serum after 12 weeks of treatment. 6) The change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897). 7) The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients). ;Timepoint(s) of evaluation of this end point: 1) Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12. 2) Quality of Life measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks. 3) Fatigue measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks. 4) Improvement in symptom burden measured with ESAS at screening and at week 4, 8 and 12. 5) 25-hydroxyvitamin D levels in blood measured at screening and after 12 weeks. 6) The change in opiod dose measured at baseline, week 4, 8 and 12 related to genetic polymorphism in genes measured at screening. 7) Frequency of AE during the whole study, and S-calcium will be controlled in all subjects at screening, at week 4, 8 and 12 and U-calcium in selected cases.	—

Measure

Time frame

Secondary end point(s): 1) Decline in antibiotic consumption (expressed as % of days with antibiotics during the last 4 weeks) based on measurements at baseline, week 4, 8 and 12. 2) Improvement in quality of life measured with EORTC-QLQ-PAL15 at screening and after 12 weeks 3) Improvement in fatigue measured with EORTC-QLQ-PAL15 at screening and after 12 weeks 4) Improvement in symptom burden measured with ESAS. 5) Levels of 25-OHD in serum after 12 weeks of treatment. 6) The change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897). 7) The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients). ;Timepoint(s) of evaluation of this end point: 1) Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12. 2) Quality of Life measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks. 3) Fatigue measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks. 4) Improvement in symptom burden measured with ESAS at screening and at week 4, 8 and 12. 5) 25-hydroxyvitamin D levels in blood measured at screening and after 12 weeks. 6) The change in opiod dose measured at baseline, week 4, 8 and 12 related to genetic polymorphism in genes measured at screening. 7) Frequency of AE during the whole study, and S-calcium will be controlled in all subjects at screening, at week 4, 8 and 12 and U-calcium in selected cases.

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Countries

Sweden

Contacts

Public ContactLinda Björkhem-Bergman

ASIH Stockholm Södra, Långbro Park

linda.bjorkhem-bergman@ki.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026