Effect of Vitamin D After Application With Valchlor

University Hospitals (UH)

Status and phase: Completed; Early Phase 1

Conditions: Skin Irritation

Treatments: Drug: Valchlor; Dietary Supplement: 4 Vitamin D; Dietary Supplement: 4 placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02968446

U01AR064144-01 (U.S. NIH Grant/Contract)

CASE3416 (Other Identifier)

09-16-36C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups, including a placebo group

Group 1: 4 placebo - 0 Vitamin D with Valchlor

Placebo Comparator group

Description:

Participants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.

Treatment:

Dietary Supplement: 4 placebo

Drug: Valchlor

Group 2: 0 placebo - 4 Vitamin D with mechloroethamine

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 4 Vitamin D

Drug: Valchlor