Phototherapy in Persons With Multiple Sclerosis

February 10, 2015 updated by: University of Illinois at Urbana-Champaign

Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study

The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Exercise Neuroscience Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female with multiple sclerosis

Exclusion Criteria:

  • Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes
  • Known medical history of calcium disorder or knowledge of high calcium levels
  • Known medical history of hyper-parathyroidism
  • Current supplementation with oral vitamin D
  • Known allergy to vitamin D
  • History of cancer of any type including but not limited to skin cancer
  • Obesity defined as BMI > 30
  • Known history of fat malabsorption conditions (i.e., steatorrhea)
  • Current use of anti-epileptic medication
  • Current use of glucocorticoids
  • Fitzpatrick skin types I and VI using the Fitzpatrick skin type analysis
  • Recent use of tanning facilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phototherapy
This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.
Device: Phototherapy
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
Placebo Comparator: Shame phototherapy
This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.
Device: Phototherapy
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
Time Frame: 0, 4, and 8 weeks
Venous blood will be collected to quantify levels of circulating Vitamin D.
0, 4, and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Walking Speed at 4 and 8 weeks
Time Frame: 0, 4, and 8 weeks
Participants will walking for 25-feet as fast, but safely, as possible on an instrumented gait mat for measuring gait speed.
0, 4, and 8 weeks
Change from Baseline in Cognitive Function at 4 and 8 weeks
Time Frame: 0, 4, and 8 weeks
Participants will complete neuropsychological assessments of processing speed and learning and memory.
0, 4, and 8 weeks
Change from Baseline in Mood State at 4 and 8 weeks
Time Frame: 0, 4, and 8 weeks
Participants will complete a 30-item self-report measure of overall mood.
0, 4, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Robert W Motl, PhD, University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15178

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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