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Effect of Vitamin D After Application With Valchlor

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ClinicalTrials.gov Identifier: NCT02968446
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kurt Lu, University Hospitals Cleveland Medical Center

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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 : November 17, 2016
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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 Name: 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 Name: 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 Name: Mechlorethamine




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968446


Contacts
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Contact: Kurt Lu, MD 216-368-2333 kurt.lu@uhhospitals.org
Contact: Mary Consolo 216-844-7834 mary.consolo@case.edu

Locations
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United States, Ohio
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kurt Lu, MD    216-368-2333    kurt.lu@case.edu   
Principal Investigator: Kurt Lu, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Kurt Lu, MD University Hospitals, Case Comprehensive Cancer Center

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Responsible Party: Kurt Lu, Assistant Professor, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02968446     History of Changes
Other Study ID Numbers: 09-16-36C
U01AR064144-01 ( U.S. NIH Grant/Contract )
CASE3416 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

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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

Keywords provided by Kurt Lu, University Hospitals Cleveland Medical Center:
Valchlor
Vitamin D
Healthy Volunteer

Additional relevant MeSH terms:
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Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Mechlorethamine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents