Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether supplementation with oral vitamin D (cholecalciferol) improves metabolic parameters in patients with moderate to severe psoriasis.

Official Title
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Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe Psoriasis

Conditions
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Psoriasis, Metabolic Syndrome, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of moderate to severe psoriasis. Being treated with methotrexate with stable doses for al least 1 month. Exclusion Criteria: Phototherapy within the past 2 months. History of psoriatic arthritis, rheumatoid arthritis, type 1 diabetes mellitus or inflammatory bowel disease. Use of vitamin d supplements or fish oil supplements in the past 2 months. Use of hypolipidemic drugs, hypoglycemic drugs, glucose sensitizers, oral corticosteroids, orlistat, cholestyramine, phenobarbital or phenytoin within the past 2 months. Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 supplementation<br>Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks. | Dietary Supplement: Vitamin D3<br>* A daily 5.000 IU vitamin D3 capsule during 6 weeks.<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks. | Dietary Supplement: Placebo<br>* A daily placebo capsule during 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol Levels |  | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Glucose Levels |  | Baseline and 6 weeks | 
| Change in HOMA Index |  | Baseline and 6 weeks | 
| Change in Glycated Hemoglobin Levels |  | Baseline and 6 weeks | 
| Change in Low-Density Lipoprotein Levels |  | Baseline and 6 weeks | 
| Change in High-Density Lipoprotein Levels |  | Baseline and 6 weeks | 
| Change in Triglycerides Levels |  | Baseline and 6 weeks | 
| Change in C-Reactive Protein Levels |  | Baseline and 6 weeks | 
| Change in Vitamin D Levels |  | Baseline and 6 weeks | 
| Change in PASI (Psoriasis Area Severity Index) |  | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI, Psoriasis Area Severity Index