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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271971
• Other study ID #: 14-412
• Status: Completed
• Phase: N/A
• First received: October 19, 2014
• Last updated: November 3, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Psoriasis
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
A daily 5.000 IU vitamin D3 capsule during 6 weeks.
• Placebo
A daily placebo capsule during 6 weeks.

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events		Baseline and 6 weeks	Yes
Primary	Change in Total Cholesterol Levels		Baseline and 6 weeks	No
Secondary	Change in Fasting Glucose Levels		Baseline and 6 weeks	No
Secondary	Change in HOMA Index		Baseline and 6 weeks	No
Secondary	Change in Glycated Hemoglobin Levels		Baseline and 6 weeks	No
Secondary	Change in Low-Density Lipoprotein Levels		Baseline and 6 weeks	No
Secondary	Change in High-Density Lipoprotein Levels		Baseline and 6 weeks	No
Secondary	Change in Triglycerides Levels		Baseline and 6 weeks	No
Secondary	Change in C-Reactive Protein Levels		Baseline and 6 weeks	No
Secondary	Change in Vitamin D Levels		Baseline and 6 weeks	No
Secondary	Change in PASI (Psoriasis Area Severity Index)		Baseline and 6 weeks	No