NCT03038516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

January 17, 2017

Last Update Submit

September 9, 2020

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (5)

  • Change in Antibiotic Consumption during 12 weeks

    12weeks

  • Change in Quality of life after 12 weeks

    12 weeks

  • Change in Fatigue after12 weeks

    12 weeks

  • Change in 25-hydroxyvitamin D levels after 12 weeks

    12 weeks

  • Change in Symptom burden during 12 weeks

    12 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Cholecalciferol (Detremin) solved in MIGLYOL® 812

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

MIGLYOL® 812

Device: Placebo

Interventions

CholecalciferolDRUG

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.

Also known as: Detremin
Vitamin D
PlaceboDEVICE

To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,

Also known as: MIGLYOL® 812
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • OHD \< 50 nmol/L.
  • Men and women aged ≥18
  • Signed 'informed consent'

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ASIH Stockholm Norr

Solna, Stockholm County, 171 54, Sweden

Location

ASIH Stockholm Södra

Älvsjö, 12559, Sweden

Location

Stockholms Sjukhem ASIH

Stockholm, 11219, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 37880704DERIVED

  • Klasson 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: 32936046DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Linda Björkhem-Bergman, Assoc Prof

    Stockholm Läns Landsting

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assoc Prof, Senior Consultant

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 31, 2017

Study Start

November 1, 2017

Primary Completion

June 9, 2020

Study Completion

June 9, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)