Metabolic Syndrome, Psoriasis, Vitamin D Deficiency
Conditions
Keywords
Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI, Psoriasis Area Severity Index
Brief summary
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.
Interventions
A daily 5.000 IU vitamin D3 capsule during 6 weeks.
A daily placebo capsule during 6 weeks.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Cholesterol Levels | Baseline and 6 weeks |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | Baseline and 6 weeks |
Countries
Chile