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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Psoriasis Area Severity Index (PASI) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plaque psoriasis diagnosis confirmed by a dermatologist at visit
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 25-Hydroxyvitamin D (Drug)
Placebo
Placebo oral capsules. Five capsules the first day and thereafter one capsule every week for 4 months.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Psoriasis Area Severity Index (PASI) score
时间窗: 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.
次要结局
- Physician Global Assessment (PGA) score(Baseline and 4 months)
- Self-administered psoriasis area and severity index (SAPASI) score(Baseline, 8 weeks and 4 months)
- Skin microbiome(Baseline and 4 months)
- Immune response in serum and the skin(Baseline and 4 months)
- Cardiometabolic marker: blood pressure(Baseline and 4 months)
- Cardiometabolic marker: lipids(Baseline and 4 months)
- Cardiometabolic marker: hip circumference(Baseline and 4 months)
- Dermatology Quality of Life Index (DLQI) score(Baseline, 8 weeks and 4 months)
- Use of psoriasis related medication: topical treatment II(Baseline, 8 weeks and 4 months)
- Long term use of psoriasis related medication(1-2 years before inclusion to 1-2 years after study end)
- Genetic expression in full blood and the skin(Baseline and 4 months)
- Use of psoriasis related medication: topical treatment I(Baseline and 4 months)
- Use of psoriasis related medication: systemic treatment(Baseline, 8 weeks and 4 months)
- Cardiometabolic marker: HbA1c(Baseline and 4 months)
- Cardiometabolic marker: Body mass index (BMI)(Baseline and 4 months)
- Cardiometabolic marker: weight(Baseline and 4 months)
- Cardiometabolic marker: waist circumference(Baseline and 4 months)