Effect of Vitamin D After Application With Valchlor

Early Phase 1

Completed

Interventions: Dietary Supplement: 4 placebo
Dietary Supplement: 4 Vitamin D
Drug: Valchlor

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Women who are pregnant, nursing, or who may become pregnant in the next 3 months
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

Arm && Interventions

Group	Intervention	Description
Group 1: 4 placebo - 0 Vitamin D with Valchlor	4 placebo	Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine	4 Vitamin D	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.
Group 1: 4 placebo - 0 Vitamin D with Valchlor	Valchlor	Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine	Valchlor	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.

Primary Outcome Measures

Name	Time	Method
Change in skin erythema	Up to 1 week after mechloroethamine exposure	Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure

Secondary Outcome Measures

Name	Time	Method
Change in skin thickness	Up to 1 week after mechloroethamine exposure	Skin thickness, an acute measure of edema, was quantified using a Mitutoyo 9mm dial caliper. Thickness measurements will be repeated in triplicate and the mean was used for all calculations. The difference in thickness between exposed and non-exposed skin will be calculated after valchlor exposure.
Change in TNF-alpha expression	Up to 120 hours after mechloroethamine exposure	A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of TNF-α will be quantified
Change in iNOS expression	Up to 120 hours after mechloroethamine exposure	A 6 mm punch biopsy specimen will be obtained from the valchlor exposure site 48hr after exposure. RNA will be extracted from fresh frozen punch biopsies using the RNeasy Lipid Mini Kit, and tissue mRNA expression of iNOS will be quantified

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