PsoriasisNCT03334136
The Effect of Vitamin D Supplementation on Psoriasis Severity
A study testing 25-Hydroxyvitamin D in people with Psoriasis and Vitamin D Deficiency, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Psoriasis, Vitamin D Deficiency
- What is being tested?
- 25-Hydroxyvitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteNorway
- Study dates
- 24 Nov 2017to 13 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Psoriasis, Vitamin D Deficiency
- Being tested
- 25-Hydroxyvitamin D, Placebo oral capsule
- Medical subject headings
- Psoriasis, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-Hydroxyvitamin DDrug
Also called Dekristol
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)
Placebo oral capsuleDrug
Five capsules the first day and thereafter one capsule every week for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | 25-hydroxyvitamin D 20.000 IU capsule given orally. Five capsules the first day and thereafter one capsule every week for 4 months. Receives: Drug: 25-Hydroxyvitamin D |
| Placebo | Placebo comparator | Placebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index (PASI) score
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.
Measured: Baseline and 4 months
Secondary outcomes (17)
Physician Global Assessment (PGA) score
The difference in change between the vitamin D and placebo group in psoriasis severity measured by PGA score.
Measured: Baseline and 4 months
Dermatology Quality of Life Index (DLQI) score
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).
Measured: Baseline, 8 weeks and 4 months
Self-administered psoriasis area and severity index (SAPASI) score
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.
Measured: Baseline, 8 weeks and 4 months
Use of psoriasis related medication: topical treatment I
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.
Measured: Baseline and 4 months
Use of psoriasis related medication: topical treatment II
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.
Measured: Baseline, 8 weeks and 4 months
Long term use of psoriasis related medication
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.
Measured: 1-2 years before inclusion to 1-2 years after study end
Use of psoriasis related medication: systemic treatment
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.
Measured: Baseline, 8 weeks and 4 months
Skin microbiome
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.
Measured: Baseline and 4 months
Immune response in serum and the skin
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.
Measured: Baseline and 4 months
Genetic expression in full blood and the skin
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.
Measured: Baseline and 4 months
Cardiometabolic marker: blood pressure
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.
Measured: Baseline and 4 months
Cardiometabolic marker: HbA1c
The difference in change between the vitamin D and placebo group in HbA1c in %. Lower value are considered to be a better outcome.
Measured: Baseline and 4 months
Cardiometabolic marker: lipids
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.
Measured: Baseline and 4 months
Cardiometabolic marker: weight
The difference in change between the vitamin D and placebo group in weight in kg. Lower values are considered to be a better outcome.
Measured: Baseline and 4 months
Cardiometabolic marker: Body mass index (BMI)
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.
Measured: Baseline and 4 months
Cardiometabolic marker: waist circumference
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
Measured: Baseline and 4 months
Cardiometabolic marker: hip circumference
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
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start24 Nov 2017
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, University of Tromso, Cornell University
- Responsible party
- Sponsor
- Investigators
- Kjersti Danielsen, MD, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334136
- Sponsor's protocol ID
- TromsøPsoriasis-2016-1
- Other IDs
- 2016-003378-42, 2016/1789, 2016
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jenssen M, Furberg AS, Jorde R, Wilsgaard T, Danielsen K. Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial. JAMA Dermatol. 2023 May 1;159(5):518-525. doi: 10.1001/jamadermatol.2023.0357.
PubMed 36988936
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03334136
- Acronym / sponsor ID
- TromsøPsoriasis-2016-1
- Conditions
- Psoriasis, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, University of Tromso, Cornell University
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: 25-Hydroxyvitamin D25-hydroxyvitamin D 20.000 IU capsule given orally. Five capsules the first day and thereafter one capsule every week for 4 months. |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25-Hydroxyvitamin DAlso: DekristolCapsules 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 | Vitamin D |
| Placebo oral capsuleFive capsules the first day and thereafter one capsule every week for 4 months. | Drug | Placebo |
Primary outcome
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.
17 secondary outcomes
Physician Global Assessment (PGA) score
Time frame: Baseline and 4 months
Dermatology Quality of Life Index (DLQI) score
Time frame: Baseline, 8 weeks and 4 months
Self-administered psoriasis area and severity index (SAPASI) score
Time frame: Baseline, 8 weeks and 4 months
Use of psoriasis related medication: topical treatment I
Time frame: Baseline and 4 months
Use of psoriasis related medication: topical treatment II
Time frame: Baseline, 8 weeks and 4 months
Long term use of psoriasis related medication
Time frame: 1-2 years before inclusion to 1-2 years after study end
Use of psoriasis related medication: systemic treatment
Time frame: Baseline, 8 weeks and 4 months
Skin microbiome
Time frame: Baseline and 4 months
Immune response in serum and the skin
Time frame: Baseline and 4 months
Genetic expression in full blood and the skin
Time frame: Baseline and 4 months
Cardiometabolic marker: blood pressure
Time frame: Baseline and 4 months
Cardiometabolic marker: HbA1c
Time frame: Baseline and 4 months
Cardiometabolic marker: lipids
Time frame: Baseline and 4 months
Cardiometabolic marker: weight
Time frame: Baseline and 4 months
Cardiometabolic marker: Body mass index (BMI)
Time frame: Baseline and 4 months
Cardiometabolic marker: waist circumference
Time frame: Baseline and 4 months
Cardiometabolic marker: hip circumference
Time frame: Baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 36988936Jenssen M, Furberg AS, Jorde R, Wilsgaard T, Danielsen K. Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial. JAMA Dermatol. 2023 May 1;159(5):518-525. doi: 10.1001/jamadermatol.2023.0357.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti Danielsen, MD, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25-Hydroxyvitamin D in people with Psoriasis and Vitamin D Deficiency, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area Severity Index (PASI) score (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.