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Trial record 16 of 705 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT02271971
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.

Condition or disease Intervention/treatment Phase
Psoriasis Metabolic Syndrome Vitamin D Deficiency Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe Psoriasis
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Vitamin D3 supplementation
Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks.
Dietary Supplement: Vitamin D3
A daily 5.000 IU vitamin D3 capsule during 6 weeks.
Other Name: Cholecalciferol

Placebo Comparator: Placebo
Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks.
Dietary Supplement: Placebo
A daily placebo capsule during 6 weeks.




Primary Outcome Measures :
  1. Change in Total Cholesterol Levels [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: Baseline and 6 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271971


Locations
Chile
Pontificia Universidad Católica de Chile
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Sergio Niklitschek, MD School of Medicine, Pontificia Universidad Católica de Chile
Principal Investigator: Ninoska Porras, MD School of Medicine, Pontificia Universidad Católica de Chile
Study Director: 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

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02271971     History of Changes
Other Study ID Numbers: 14-412
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by Pontificia Universidad Catolica de Chile:
Psoriasis
Vitamin D
Metabolic syndrome
Insulin resistance
Cholesterol
Methotrexate
Dyslipidemia
PASI
Psoriasis Area Severity Index

Additional relevant MeSH terms:
Psoriasis
Metabolic Syndrome X
Vitamin D Deficiency
Skin Diseases, Papulosquamous
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents