Effect of Vitamin D After Application With Valchlor

The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical 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.

Study Overview

• Status: Completed
• Conditions: Skin Irritation
• Intervention / Treatment: Dietary supplement: 4 placebo; Drug: Valchlor; Dietary supplement: 4 Vitamin D

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin erythema	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	Up to 1 week after mechloroethamine exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin thickness	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.	Up to 1 week after mechloroethamine exposure
Change in TNF-alpha expression	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	Up to 120 hours after mechloroethamine exposure
Change in iNOS expression	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	Up to 120 hours after mechloroethamine exposure

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kurt Lu, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Healthy Volunteer; Valchlor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Mechlorethamine
• Other Study ID Numbers: 09-16-36C; U01AR064144-01 (U.S. NIH Grant/Contract); CASE3416 (Other Identifier: Case Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No