Clinical Trials /

Effect of Vitamin D After Application With Valchlor

NCT02968446

Description:

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.

Recruiting Status:

Unknown status

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT02968446

Trial Eligibility

Document

Title

  • Brief Title: Effect of Vitamin D After Application With Valchlor
  • Official Title: The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor

Clinical Trial IDs

  • ORG STUDY ID: 09-16-36C
  • SECONDARY ID: U01AR064144-01
  • SECONDARY ID: CASE3416
  • NCT ID: NCT02968446

Conditions

  • Skin Irritation

Interventions

DrugSynonymsArms
ValchlorMechlorethamineGroup 1: 4 placebo - 0 Vitamin D with Valchlor

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Group 1: 4 placebo - 0 Vitamin D with ValchlorPlacebo ComparatorParticipants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
  • Valchlor
Group 2: 0 placebo - 4 Vitamin D with mechloroethamineExperimentalParticipants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.
  • Valchlor

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in skin erythema
Time Frame:Up to 1 week after mechloroethamine exposure
Safety Issue:
Description: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

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:University Hospitals Cleveland Medical Center

Trial Keywords

  • Valchlor
  • Vitamin D
  • Healthy Volunteer

Last Updated

November 20, 2017