NCT02968446

Effect of Vitamin D After Application With Valchlor

The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system. 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

Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose. Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.

Conditions

• Skin Irritation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	4 Vitamin D	subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
DRUG	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

Timeline

• Start date: 2016-11-17
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2016-11-18
• Last updated: 2021-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study