Clinical trial NCT02271971: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Metabolic Syndrome
Vitamin D Deficiency
Keywords: Psoriasis
Vitamin D
Metabolic syndrome
Insulin resistance
Cholesterol
Methotrexate
Dyslipidemia
PASI
Psoriasis Area Severity Index
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Total Cholesterol Levels
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Fasting Glucose Levels
timeFrame: Baseline and 6 weeks
measure: Change in HOMA Index
timeFrame: Baseline and 6 weeks
measure: Change in Glycated Hemoglobin Levels
timeFrame: Baseline and 6 weeks
measure: Change in Low-Density Lipoprotein Levels
timeFrame: Baseline and 6 weeks
measure: Change in High-Density Lipoprotein Levels
timeFrame: Baseline and 6 weeks
measure: Change in Triglycerides Levels
timeFrame: Baseline and 6 weeks
measure: Change in C-Reactive Protein Levels
timeFrame: Baseline and 6 weeks
measure: Change in Vitamin D Levels
timeFrame: Baseline and 6 weeks
measure: Change in PASI (Psoriasis Area Severity Index)
timeFrame: Baseline and 6 weeks
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Baseline and 6 weeks
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
state: Región Metropolitana
Study officials:
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Sergio Niklitschek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Ninoska Porras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Hernán Correa, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Félix Fich, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Isidora Harz, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Arturo Borzutzky, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Luis Villarroel, MD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: William Romero, MD
role: STUDY_DIRECTOR
References: