Phototherapy in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02365259
• Other study ID #: 15178
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 2, 2015
• Last updated: February 10, 2015
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2015
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Exercise Neuroscience Research Laboratory	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No