Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
33 participants
INTERVENTIONAL
2016-11-17
2018-10-01
Brief Summary
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An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.
Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
Detailed Description
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Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group 1: 4 placebo - 0 Vitamin D with Valchlor
Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
4 placebo
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
Valchlor
Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
Participants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.
4 Vitamin D
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
Valchlor
Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
Interventions
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4 placebo
subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
4 Vitamin D
subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
Valchlor
Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick Skin Type I-VI
* Able to list all current medications and medical conditions
* Capable of giving informed consent
Exclusion Criteria
* Participants taking illegal drugs
* Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
* Currently consuming 800IU or more of vitamin D a day
* Subjects whose BMI are \> 40
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Kurt Lu
Assistant Professor
Principal Investigators
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Kurt Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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References
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Ernst MK, Evans ST, Techner JM, Rothbaum RM, Christensen LF, Onay UV, Biyashev D, Demczuk MM, Nguyen CV, Honda KS, McCormick TS, Tsoi LC, Gudjonsson JE, Cooper KD, Lu KQ. Vitamin D3 and deconvoluting a rash. JCI Insight. 2023 Jan 24;8(2):e163789. doi: 10.1172/jci.insight.163789.
Other Identifiers
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CASE3416
Identifier Type: OTHER
Identifier Source: secondary_id
09-16-36C
Identifier Type: -
Identifier Source: org_study_id