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Phototherapy in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Exercise Neuroscience Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phototherapy

Shame phototherapy

Arm Description

This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.

This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.

Outcomes

Primary Outcome Measures

Change from Baseline in Serum Vitamin D at 4 and 8 weeks
Venous blood will be collected to quantify levels of circulating Vitamin D.

Secondary Outcome Measures

Change from Baseline in Walking Speed at 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.
Change from Baseline in Cognitive Function at 4 and 8 weeks
Participants will complete neuropsychological assessments of processing speed and learning and memory.
Change from Baseline in Mood State at 4 and 8 weeks
Participants will complete a 30-item self-report measure of overall mood.

Full Information

First Posted
February 2, 2015
Last Updated
February 10, 2015
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT02365259
Brief Title
Phototherapy in Persons With Multiple Sclerosis
Official Title
Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy
Arm Type
Experimental
Arm Description
This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.
Arm Title
Shame phototherapy
Arm Type
Placebo Comparator
Arm Description
This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.
Intervention Type
Device
Intervention Name(s)
Phototherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
Description
Venous blood will be collected to quantify levels of circulating Vitamin D.
Time Frame
0, 4, and 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Walking Speed at 4 and 8 weeks
Description
Participants will walking for 25-feet as fast, but safely, as possible on an instrumented gait mat for measuring gait speed.
Time Frame
0, 4, and 8 weeks
Title
Change from Baseline in Cognitive Function at 4 and 8 weeks
Description
Participants will complete neuropsychological assessments of processing speed and learning and memory.
Time Frame
0, 4, and 8 weeks
Title
Change from Baseline in Mood State at 4 and 8 weeks
Description
Participants will complete a 30-item self-report measure of overall mood.
Time Frame
0, 4, and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Motl, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Neuroscience Research Laboratory
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

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Phototherapy in Persons With Multiple Sclerosis

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