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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Metabolic Syndrome; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Pontificia Universidad Catolica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	Baseline and 6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 19, 2014
• First Submitted That Met QC Criteria: October 19, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Psoriasis; Vitamin D; Metabolic syndrome; Insulin resistance; Cholesterol; Methotrexate; Dyslipidemia; PASI; Psoriasis Area Severity Index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Nutrition Disorders; Skin Diseases, Papulosquamous; Insulin Resistance; Hyperinsulinism; Avitaminosis; Deficiency Diseases; Malnutrition; Psoriasis; Metabolic Syndrome; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 14-412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No