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

Primary Purpose

Psoriasis, Metabolic Syndrome, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI, Psoriasis Area Severity Index

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Pontificia Universidad Católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 supplementation

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Total Cholesterol Levels

Secondary Outcome Measures

Change in Fasting Glucose Levels

Change in HOMA Index

Change in Glycated Hemoglobin Levels

Change in Low-Density Lipoprotein Levels

Change in High-Density Lipoprotein Levels

Change in Triglycerides Levels

Change in C-Reactive Protein Levels

Change in Vitamin D Levels

Change in PASI (Psoriasis Area Severity Index)

Full Information

NCT ID

NCT02271971

First Posted

October 19, 2014

Last Updated

November 3, 2015

Sponsor

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT02271971

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Metabolic Syndrome, Vitamin D Deficiency

Keywords

Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI, Psoriasis Area Severity Index

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 supplementation

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

A daily placebo capsule during 6 weeks.

Primary Outcome Measure Information:

Title

Change in Total Cholesterol Levels

Time Frame

Baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Change in Fasting Glucose Levels

Time Frame

Baseline and 6 weeks

Title

Change in HOMA Index

Time Frame

Baseline and 6 weeks

Title

Change in Glycated Hemoglobin Levels

Time Frame

Baseline and 6 weeks

Title

Change in Low-Density Lipoprotein Levels

Time Frame

Baseline and 6 weeks

Title

Change in High-Density Lipoprotein Levels

Time Frame

Baseline and 6 weeks

Title

Change in Triglycerides Levels

Time Frame

Baseline and 6 weeks

Title

Change in C-Reactive Protein Levels

Time Frame

Baseline and 6 weeks

Title

Change in Vitamin D Levels

Time Frame

Baseline and 6 weeks

Title

Change in PASI (Psoriasis Area Severity Index)

Time Frame

Baseline and 6 weeks

Other Pre-specified Outcome Measures:

Title

Number of Participants with Adverse Events

Time Frame

Baseline and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergio Niklitschek, MD

Organizational Affiliation