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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Psoriasis Metabolic Syndrome Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3 supplementation

Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Placebo

Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A daily placebo capsule during 6 weeks.

Interventions

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Vitamin D3

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A daily placebo capsule during 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR