Psoriasis, Vitamin D Deficiency
Conditions
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.
Interventions
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)
DRUGPlacebo oral capsule
Five capsules the first day and thereafter one capsule every week for 4 months.
Sponsors
The Royal Norwegian Ministry of Health
University of Tromso
Cornell University
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area Severity Index (PASI) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment (PGA) score | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Immune response in serum and the skin | 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. |
| Skin microbiome | 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. |
| Cardiometabolic marker: blood pressure | 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 | 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 | 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 | 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) | 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 | 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 | 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 |
| Genetic expression in full blood and the skin | 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. |
Countries
Norway
Outcome results
None listed