Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment phototherapy
Phase phase 1
Sponsor University of Illinois at Urbana-Champaign
Start date January 2015
End date February 2016
Trial size 20 participants
Trial identifier NCT02365259, 15178

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.
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)
This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.
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 Outcomes

Measure
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
time frame: 0, 4, and 8 weeks

Secondary Outcomes

Measure
Change from Baseline in Walking Speed at 4 and 8 weeks
time frame: 0, 4, and 8 weeks
Change from Baseline in Cognitive Function at 4 and 8 weeks
time frame: 0, 4, and 8 weeks
Change from Baseline in Mood State at 4 and 8 weeks
time frame: 0, 4, and 8 weeks

Eligibility Criteria

Female participants from 18 years up to 64 years old.

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

Additional Information

Official title Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
Principal investigator Robert W Motl, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign.