Phototherapy in Persons With Multiple Sclerosis
Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
1 other identifier
interventional
20
1 country
1
Brief Summary
The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-sclerosis
Started Jan 2015
Shorter than P25 for phase_1 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 18, 2015
February 1, 2015
1.1 years
February 2, 2015
February 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change from Baseline in Walking Speed at 4 and 8 weeks
0, 4, and 8 weeks
Change from Baseline in Cognitive Function at 4 and 8 weeks
0, 4, and 8 weeks
Change from Baseline in Mood State at 4 and 8 weeks
0, 4, and 8 weeks
Study Arms (2)
Phototherapy
EXPERIMENTALThis arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.
Shame phototherapy
PLACEBO COMPARATORThis arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female with multiple sclerosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Exercise Neuroscience Research Laboratory
Urbana, Illinois, 61801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W Motl, PhD
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 18, 2015
Study Start
January 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 18, 2015
Record last verified: 2015-02