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'Palliative-D' Vitamin D to Palliative Cancer Patients (Palliative-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03038516
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Linda Björkhem-Bergman, Stockholm County Council, Sweden

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Cholecalciferol Device: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : June 9, 2020
Actual Study Completion Date : June 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Cholecalciferol (Detremin) solved in MIGLYOL® 812
Drug: Cholecalciferol
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.
Other Name: Detremin

Placebo Comparator: Placebo
MIGLYOL® 812
Device: Placebo
To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,
Other Name: MIGLYOL® 812




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Antibiotic Consumption during 12 weeks [ Time Frame: 12weeks ]
    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.

  2. Change in Quality of life after 12 weeks [ Time Frame: 12 weeks ]
    Change in Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.

  3. Change in Fatigue after12 weeks [ Time Frame: 12 weeks ]
    Change in Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.

  4. Change in 25-hydroxyvitamin D levels after 12 weeks [ Time Frame: 12 weeks ]
    Change in 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks.

  5. Change in Symptom burden during 12 weeks [ Time Frame: 12 weeks ]
    Change in Symptom burden measured with ESAS (Edmonton Symptom Assessment Scale) at baseline and at week 4, 8 and 12.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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'

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038516


Locations
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Sweden
ASIH Stockholm Norr
Solna, Stockholm, Sweden, 171 54
Stockholms Sjukhem ASIH
Stockholm, Sweden, 11219
ASIH Stockholm Södra
Älvsjö, Sweden, 12559
Sponsors and Collaborators
Stockholm County Council, Sweden
Investigators
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Principal Investigator: Linda Björkhem-Bergman, Assoc Prof Stockholm Läns Landsting
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Linda Björkhem-Bergman, MD, PhD, Assoc Prof, Senior Consultant, Stockholm County Council, Sweden
ClinicalTrials.gov Identifier: NCT03038516    
Other Study ID Numbers: Palliative-D
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents