Effect of Vitamin D After Application With Valchlor

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02968446

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

Enrollment

Location

Arms

22.4

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Irritation	Dietary Supplement: 4 placebo Dietary Supplement: 4 Vitamin D Drug: Valchlor	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 17, 2016

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	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 Other Names: placebo 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 Other Names: Mechlorethamine
Experimental: 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.	Dietary Supplement: 4 Vitamin D subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol) Other Names: 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 Other Names: Mechlorethamine

Arm

Intervention/Treatment

Placebo Comparator: 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.

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

Other Names:

placebo

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

Other Names:

Mechlorethamine

Experimental: 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.

Dietary Supplement: 4 Vitamin D

subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)

Other Names:

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

Other Names:

Mechlorethamine

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be in general good health
Fitzpatrick Skin Type I-VI
Able to list all current medications and medical conditions
Capable of giving informed consent

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