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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Completed

CT.gov ID

NCT02271971

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Metabolic Syndrome Vitamin D Deficiency	Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D3 supplementation Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks.	Dietary Supplement: Vitamin D3 A daily 5.000 IU vitamin D3 capsule during 6 weeks. Other Names: Cholecalciferol
Placebo Comparator: Placebo Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks.	Dietary Supplement: Placebo A daily placebo capsule during 6 weeks.

Arm

Intervention/Treatment

Experimental: Vitamin D3 supplementation

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

Dietary Supplement: Vitamin D3

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Other Names:

Cholecalciferol

Placebo Comparator: Placebo

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

Dietary Supplement: Placebo

A daily placebo capsule during 6 weeks.

Outcome Measures

Primary Outcome Measures

Change in Total Cholesterol Levels [Baseline and 6 weeks]

Secondary Outcome Measures

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 Outcome Measures

Number of Participants with Adverse Events [Baseline and 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontificia Universidad Católica de Chile	Santiago	Región Metropolitana	Chile

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Investigators

Principal Investigator: Sergio Niklitschek, MD, School of Medicine, Pontificia Universidad Católica de Chile
Principal Investigator: Ninoska Porras, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: Hernán Correa, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: Félix Fich, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: Isidora Harz, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: Arturo Borzutzky, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: Luis Villarroel, MD, School of Medicine, Pontificia Universidad Católica de Chile
Study Director: William Romero, MD, School of Medicine, Pontificia Universidad Católica de Chile