Phototherapy in Persons With Multiple Sclerosis

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

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phototherapy<br>This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks. | Device: Phototherapy<br>* 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.<br>|
| Placebo Comparator: Shame phototherapy<br>This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light. | Device: Phototherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Serum Vitamin D at 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 | 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 | 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 | Participants will complete a 30-item self-report measure of overall mood. | 0, 4, and 8 weeks |