NCT02365259

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

February 2, 2015

Last Update Submit

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

EXPERIMENTAL

This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.

Device: Phototherapy

Shame phototherapy

PLACEBO COMPARATOR

This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.

Device: Phototherapy

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.

PhototherapyShame phototherapy

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Robert W Motl, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

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

Locations