NCT02271971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

October 19, 2014

Last Update Submit

November 3, 2015

Conditions

PsoriasisMetabolic SyndromeVitamin D Deficiency

Keywords

PsoriasisVitamin DMetabolic syndromeInsulin resistanceCholesterolMethotrexateDyslipidemiaPASIPsoriasis Area Severity Index

Outcome Measures

Primary Outcomes (1)

  • Change in Total Cholesterol Levels

    Baseline and 6 weeks

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Other Outcomes (1)

  • Number of Participants with Adverse Events

    Baseline and 6 weeks

Study Arms (2)

Vitamin D3 supplementation

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Also known as: Cholecalciferol
Vitamin D3 supplementation
PlaceboDIETARY_SUPPLEMENT

A daily placebo capsule during 6 weeks.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of moderate to severe psoriasis.
  • Being treated with methotrexate with stable doses for al least 1 month.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

PsoriasisMetabolic SyndromeVitamin D DeficiencyInsulin ResistanceDyslipidemias

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sergio Niklitschek, MD

    School of Medicine, Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

  • Ninoska Porras, MD

    School of Medicine, Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

CL(1)