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Trial record 26 of 28 for:    multiple sclerosis | vitamin D

Phototherapy in Persons With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365259
Recruitment Status : Unknown
Verified February 2015 by University of Illinois at Urbana-Champaign.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Phototherapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
Study Start Date : January 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02365259


Locations
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United States, Illinois
Exercise Neuroscience Research Laboratory
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Robert W Motl, PhD University of Illinois at Urbana-Champaign

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02365259     History of Changes
Other Study ID Numbers: 15178
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases