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OpenTrials
Completed

NCT Number: NCT02271971

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

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Key information

Conditions

Psoriasis Avitaminosis Deficiency Diseases Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Malnutrition Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Vitamin D Deficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

A daily 5.000 IU vitamin D3 capsule during 6 weeks.

Other names: Cholecalciferol

Placebo

Dietary Supplement

A daily placebo capsule during 6 weeks.

Primary outcomes

  1. Change in Total Cholesterol Levels

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Change in Fasting Glucose Levels

    Time frame: Baseline and 6 weeks

  2. Change in HOMA Index

    Time frame: Baseline and 6 weeks

  3. Change in Glycated Hemoglobin Levels

    Time frame: Baseline and 6 weeks

  4. Change in Low-Density Lipoprotein Levels

    Time frame: Baseline and 6 weeks

  5. Change in High-Density Lipoprotein Levels

    Time frame: Baseline and 6 weeks

  6. Change in Triglycerides Levels

    Time frame: Baseline and 6 weeks

  7. Change in C-Reactive Protein Levels

    Time frame: Baseline and 6 weeks

  8. Change in Vitamin D Levels

    Time frame: Baseline and 6 weeks

  9. Change in PASI (Psoriasis Area Severity Index)

    Time frame: Baseline and 6 weeks

Other outcomes

  1. Number of Participants with Adverse Events

    Time frame: Baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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