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The Effect of Vitamin D Supplementation on Psoriasis Severity

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ClinicalTrials.gov Identifier: NCT03334136
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
The Royal Norwegian Ministry of Health
University of Tromso
Cornell University
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE November 24, 2017
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Psoriasis Area Severity Index (PASI) score [ Time Frame: Baseline and 4 months ]
The difference in change between the vitamin D and placebo group in psoriasis severity measured by PASI score. Score range from 0-72, where a higher value indicates a more severe disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03334136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • Physician Global Assessment (PGA) score [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in psoriasis severity measured by PGA score.
  • Dermatology Quality of Life Index (DLQI) score [ Time Frame: Baseline, 8 weeks and 4 months ]
    The difference in change between the vitamin D and placebo group in self-reported quality of life measured by DLQI score. Score range from 0-30 (0-1 = no effect at all on patient's life; 2-5 = small effect on patient's life; 6-10 = moderate effect on patient's life; 11-20 = very large effect on patient's life; 21-30 = extremely large effect on patient's life).
  • Self-administered psoriasis area and severity index (SAPASI) score [ Time Frame: Baseline, 8 weeks and 4 months ]
    The difference in change between the vitamin D and placebo group in self-reported psoriasis severity measured by SAPASI score. Score range from 0-72, where a higher value indicates a more severe disease.
  • Use of psoriasis related medication: topical treatment I [ Time Frame: Baseline and 4 months ]
    Difference in use of topical treatment measured in grams measured by type (steroid group 1-4) and amount (in milligram) between individuals in the vitamin D and placebo group. Participants will be asked to bring their current topical medication to the first appointment and the medication will be registered and weighed in grams. They will be asked to save any tube of medication which is used during the duration of the study and bring this back for the last visit. Use of medication will be used as a proxy for severity and statistical adjustment variable.
  • Use of psoriasis related medication: topical treatment II [ Time Frame: Baseline, 8 weeks and 4 months ]
    Difference in use of topical medication measured by the type of topical treatment (steroid group 1-4) and amount of prescriptions given between individuals in the vitamin D and placebo group. Data will be collected through self-report and data on number of prescriptions given from Norwegian Prescription database by ATC code. Use of medication will be used as a proxy for severity and statistical adjustment variable.
  • Long term use of psoriasis related medication [ Time Frame: 1-2 years before inclusion to 1-2 years after study end ]
    Difference between use of topical and/or systemic psoriasis related medication, measured through type and number of psoriasis relevant prescriptions given (data from Norwegian Prescription database by ATC code) between individuals in the vitamin D and placebo group.
  • Use of psoriasis related medication: systemic treatment [ Time Frame: Baseline, 8 weeks and 4 months ]
    Difference in use of systemic psoriasis medication between individuals in the Vitamin D and placebo group. Data will be collected through self-report and data on number of prescriptions given from Norwegian Prescription database by ATC code. Use of medication will be used as a proxy for severity and statistical adjustment variable.
  • Skin microbiome [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in skin microbiome measured by 16s rRNA sequencing also compared with skin microbiome of participants with low serum vitamin D, but without psoriasis.
  • Immune response in serum and the skin [ Time Frame: Baseline and 4 months ]
    The investigators wish to measure changes in immune response including use of inflammatory/metabolomic markers using serum and skin biopsies (healthy and plaque skin) between the study arms (placebo versus intervention with vitamin D) before and after intervention. Details concerning chosen study panel and methods will be decided in detail later based on study findings.
  • Genetic expression in full blood and the skin [ Time Frame: Baseline and 4 months ]
    The investigators wish to measure changes in genetic expression including possible transcriptomic and proteomic analyses using full blood and skin biopsies (healthy and plaque skin) between the study arms (placebo versus intervention with vitamin D) before and after intervention. Details concerning methods will be decided in detail later based on study findings.
  • Cardiometabolic marker: blood pressure [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in blood pressure(BP) in mmHg. Both systolic BP and diastolic BP will be measured. Lower values are considered to be a better outcome.
  • Cardiometabolic marker: HbA1c [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in HbA1c in %. Lower value are considered to be a better outcome.
  • Cardiometabolic marker: lipids [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in lipids(total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) in mmol/L. Lower values of total cholesterol, LDL-cholesterol and triglycerides, and higher value of HDL-cholesterol, are considered to be a better outcome.
  • Cardiometabolic marker: weight [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in weight in kg. Lower values are considered to be a better outcome.
  • Cardiometabolic marker: Body mass index (BMI) [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in body mass index (weight/ height*height; kg/m2). Lower values are considered to be a better outcome.
  • Cardiometabolic marker: waist circumference [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in waist circumference in cm. Lower values are considered to be a better outcome
  • Cardiometabolic marker: hip circumference [ Time Frame: Baseline and 4 months ]
    The difference in change between the vitamin D and placebo group in hip circumference in cm. Lower values are considered to be a better outcome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin D Supplementation on Psoriasis Severity
Official Title  ICMJE The Effect of Vitamin D Supplementation on Psoriasis Severity Measured by Psoriasis Area Severity Index (PASI) in Patients With Lower Range Serum 25-hydroxyvitamin D Levels
Brief Summary The study evaluates the effect of oral vitamin D supplementation on the severity of psoriasis measured by Psoriasis Area Severity Index (PASI) in adults with lower vitamin D levels. Half of the participants will receive vitamin D, while the other half receive placebo.
Detailed Description

Studies have indicated an association between lower levels of vitamin D and increased risk of psoriasis. This study investigate if vitamin D supplementation can reduce the severity of the skin disease as measured by Psoriasis Area Severity Index (PASI), as well as positively influence the cardiometabolic profile and skin microbiota of persons with psoriasis through a winter season.

Consenting participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for four months. The participants will be recruited based on their 25-hydroxyvitamin D (25(OH)D)-measurements in the 7th survey in the Tromsø study where 21.083 subjects attended.

In order to assure sufficient study participation we will (in season 2, winter 2018/19) include 20-40 persons from the general population in Tromsø aged 20-79, who did not partake in Tromsø 7, through advertisement and contact with patient organizations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Vitamin D Deficiency
Intervention  ICMJE
  • Drug: 25-Hydroxyvitamin D
    Capsules containing 20 000 IU 25-hydroxyvitamin D given orally: five capsules the first day and thereafter one capsule every week for 4 months (average daily dose approximately 3.000 IU)
    Other Name: Dekristol
  • Drug: Placebo oral capsule
    Five capsules the first day and thereafter one capsule every week for 4 months.
Study Arms  ICMJE
  • Active Comparator: Vitamin D
    25-hydroxyvitamin D 20.000 IU capsule given orally. Five capsules the first day and thereafter one capsule every week for 4 months.
    Intervention: Drug: 25-Hydroxyvitamin D
  • Placebo Comparator: Placebo
    Placebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Plaque psoriasis diagnosis confirmed by a dermatologist at visit 1.
  • Psoriasis Area Severity Index (PASI) score > 0 at inclusion.
  • Serum 25 hydroxyvitamin D levels < 60 nmol/L confirmed at visit 1
  • Do not meet exclusion criteria

Exclusion Criteria:

  • age above 79 years
  • subjects allergic to nuts (the study capsules contain peanut oil)
  • subjects with primary hyperparathyroidism
  • granulomatous diseases (sarcoidosis, tuberculosis, granulomatosis with polyangiitis (Wegners))
  • reduced kidney function (creatinine > 130 μmol/L in males and 120 μmol/L in females)
  • measured systolic blood pressure (BP) > 174 mmHg, diastolic BP > 104 mmHg
  • poorly controlled diabetes (HbA1c > 9.0 %)
  • renal stones the last five years
  • subjects who use solarium on a regular basis (more than twice a month on average), nor can this be performed under the course of the study
  • subjects who plan holiday(s) in tropical areas including the Canary Islands for more than two weeks under the course of the study
  • subjects with clinical signs of proximal myopathy (problems with standing up from chair or walking stairs)
  • subjects seriously physically or mentally ill and unfit for participation in a clinical study (as judged by one of the study doctors)
  • subjects who have been diagnosed with or treated for organ cancer within the past 12 months (basal cell carcinoma and other limited nonmelanoma skin cancer or melanoma in situ can be included).
  • pregnancy. Females of child bearing potential (below the age of 50) may participate if they use highly effective anticonception (hormonal, intrauterine device(IUD), in accordance with Clinical Trial Facilitation Group(CTFG) guidelines); if living in a relation with a partner who has been sterilized; if living in a lesbian relationship; or do not have or wish to have a male partner. If, in spite of the above, a pregnancy occurs during the study, it will lead to exclusion form the study. In females < 50 years a pregnancy test will be performed at inclusion
  • subjects using vitamin D supplementation (incl. cod liver oil) above 800 IU (20 microgram) (5 ml codliver oil = 400 IU) or active vitamin D drugs (Rocaltrol or Etalpha) within the last month before study start are excluded. Furthermore, vitamin D supplements (e.g. codliver oil) or drugs apart from the study medication can not be used during the course of the study.
  • subjects who during the last month before inclusion have used phototherapy/light therapy or heliotherapy as prescribed by a dermatologist, nor can this treatment be performed under the course of the study
  • subjects who have started treatment with a new oral or injection drug for psoriasis or psoriasis arthritis (E.g. Methotrexate, Cyclosporine, Acitretin or biological treatment like Humira, Remicade, Stelara and others ) within the last 2 months (evaluated by dermatologist). Nor can a new oral or injection drug which influences psoriasis severity be introduced during the study. In this case the participant will be withdrawn from the study.
  • subjects who have participated (been randomized) in the pilot study
  • In season 1: subjects who have participated (been randomized) in the D-COR study.

Topical treatments containing vitamin D or vitamin D analogs (including Daivobet) cannot be used during the study. If a subject uses these products regularly, replacement products which only contain local steroids will be prescribed as alternates or the participant is excluded.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kjersti Danielsen, MD, PhD +47 476 05 092 kjerstidanielsen2007@hotmail.com
Contact: Marita Jenssen, MD +47 416 44 690 marita.jenssen@unn.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03334136
Other Study ID Numbers  ICMJE TromsøPsoriasis-2016-1
2016-003378-42 ( EudraCT Number )
2016/1789 ( Other Identifier: The Regional Ethics Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE
  • The Royal Norwegian Ministry of Health
  • University of Tromso
  • Cornell University
Investigators  ICMJE
Principal Investigator: Kjersti Danielsen, MD, PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP