PsoriasisNCT02271971

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

A study testing Vitamin D3 in people with Psoriasis and Metabolic Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Psoriasis, Metabolic Syndrome, Vitamin D Deficiency
What is being tested?: Vitamin D3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteChile
Study dates: Oct 2014to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe 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.

Conditions: Psoriasis, Metabolic Syndrome, Vitamin D Deficiency
Being tested: Vitamin D3, Placebo
Keywords: Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI, Psoriasis Area Severity Index
Medical subject headings: Psoriasis, Metabolic Syndrome, Vitamin D Deficiency, Insulin Resistance, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Dietary supplement
Also called Cholecalciferol
A daily 5.000 IU vitamin D3 capsule during 6 weeks.
PlaceboDietary supplement
A daily placebo capsule during 6 weeks.

Study groups in NCT02271971
Study group	Role	What they receive
Vitamin D3 supplementation	Experimental	Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks. Receives: Dietary Supplement: Vitamin D3
Placebo	Placebo comparator	Subjects in the placebo arm will receive a daily placebo capsule during 6 weeks. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Cholesterol Levels
Measured: Baseline and 6 weeks

Secondary outcomes (9)

Change in Fasting Glucose Levels
Measured: Baseline and 6 weeks
Change in HOMA Index
Measured: Baseline and 6 weeks
Change in Glycated Hemoglobin Levels
Measured: Baseline and 6 weeks
Change in Low-Density Lipoprotein Levels
Measured: Baseline and 6 weeks
Change in High-Density Lipoprotein Levels
Measured: Baseline and 6 weeks
Change in Triglycerides Levels
Measured: Baseline and 6 weeks
Change in C-Reactive Protein Levels
Measured: Baseline and 6 weeks
Change in Vitamin D Levels
Measured: Baseline and 6 weeks
Change in PASI (Psoriasis Area Severity Index)
Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Oct 2015

First posted22 Oct 2014 (estimated)
Study startOct 2014
Primary completionApr 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02271971
Sponsor's protocol ID: 14-412
Status last verified: Nov 2015
First submitted: 19 Oct 2014
Last updated: 4 Nov 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT02271971
Acronym / sponsor ID: 14-412
Conditions: Psoriasis, Metabolic Syndrome, Vitamin D Deficiency
Keywords: Psoriasis, Vitamin D, Metabolic syndrome, Insulin resistance, Cholesterol, Methotrexate, Dyslipidemia, PASI
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Pontificia Universidad Catolica de ChileUniversity, hospital or other
Study start: Oct 2014
Primary completion: Apr 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 22 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vitamin D3 supplementation	Experimental	Dietary Supplement: Vitamin D3Subjects in the experimental arm will receive a daily 5.000 IU vitamin D3 capsule during 6 weeks.
Placebo	Placebo comparator	Dietary Supplement: PlaceboSubjects in the placebo arm will receive a daily placebo capsule during 6 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Also: CholecalciferolA daily 5.000 IU vitamin D3 capsule during 6 weeks.	Dietary supplement	Vitamin D3 supplementation
PlaceboA daily placebo capsule during 6 weeks.	Dietary supplement	Placebo

Primary outcome

Change in Total Cholesterol Levels
Time frame: Baseline and 6 weeks

9 secondary outcomes

Change in Fasting Glucose Levels
Time frame: Baseline and 6 weeks
Change in HOMA Index
Time frame: Baseline and 6 weeks
Change in Glycated Hemoglobin Levels
Time frame: Baseline and 6 weeks
Change in Low-Density Lipoprotein Levels
Time frame: Baseline and 6 weeks
Change in High-Density Lipoprotein Levels
Time frame: Baseline and 6 weeks
Change in Triglycerides Levels
Time frame: Baseline and 6 weeks
Change in C-Reactive Protein Levels
Time frame: Baseline and 6 weeks
Change in Vitamin D Levels
Time frame: Baseline and 6 weeks
Change in PASI (Psoriasis Area Severity Index)
Time frame: Baseline and 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sergio Niklitschek, MD principal investigator

School of Medicine, Pontificia Universidad Católica de Chile

Ninoska Porras, MD principal investigator

School of Medicine, Pontificia Universidad Católica de Chile

Hernán Correa, MD study director

School of Medicine, Pontificia Universidad Católica de Chile

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 in people with Psoriasis and Metabolic Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Cholesterol Levels (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02271971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.