Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 79 Years|
- - 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.
- - subjects using vitamin D supplementation (incl.
- - 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.
- - subjects who have participated (been randomized) in the pilot study - In season 1: subjects who have participated (been randomized) in the D-COR study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital of North Norway|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kjersti Danielsen, MD, PhD|
|Principal Investigator Affiliation||University Hospital of North Norway|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Psoriasis, Vitamin D Deficiency|
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.
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.
Placebo Comparator: Placebo
Placebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months.
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)
Drug: - Placebo oral capsule
Five capsules the first day and thereafter one capsule every week for 4 months.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.