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Completed

NCT Number: NCT02968446

Effect of Vitamin D After Application With Valchlor

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.

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Key information

Conditions

Skin Irritation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 placebo

Dietary Supplement

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

4 Vitamin D

Dietary Supplement

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

Other names: cholecalciferol

Valchlor

Drug

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

Primary outcomes

  1. Change in skin erythema

    Time frame: 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 outcomes

  1. Change in skin thickness

    Time frame: 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.

  2. Change in TNF-alpha expression

    Time frame: 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

  3. Change in iNOS expression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2016
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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