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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Vitamin D Deficiency; Psoriasis
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT02271971
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-19
• Study First Submitted QC: 2014-10-19
• Study First Posted: 2014-10-22
• Primary Completion: 2015-04
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 supplementation	Vitamin D3	Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks.
Placebo	Placebo	Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Total Cholesterol Levels	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Glucose 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
Change in HOMA Index	Baseline and 6 weeks
Change in Glycated Hemoglobin Levels	Baseline and 6 weeks

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile