NCT02968446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

November 16, 2016

Last Update Submit

December 6, 2021

Conditions

Skin Irritation

Keywords

ValchlorVitamin DHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in skin thickness

    Up to 1 week after mechloroethamine exposure

  • Change in TNF-alpha expression

    Up to 120 hours after mechloroethamine exposure

  • Change in iNOS expression

    Up to 120 hours after mechloroethamine exposure

Study Arms (2)

Group 1: 4 placebo - 0 Vitamin D with Valchlor

PLACEBO COMPARATOR

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

Dietary Supplement: 4 placeboDrug: Valchlor

Group 2: 0 placebo - 4 Vitamin D with mechloroethamine

EXPERIMENTAL

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 DDrug: Valchlor

Interventions

4 placeboDIETARY_SUPPLEMENT

subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills

Also known as: placebo
Group 1: 4 placebo - 0 Vitamin D with Valchlor
4 Vitamin DDIETARY_SUPPLEMENT

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

Also known as: cholecalciferol
Group 2: 0 placebo - 4 Vitamin D with mechloroethamine
ValchlorDRUG

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

Also known as: Mechlorethamine
Group 1: 4 placebo - 0 Vitamin D with ValchlorGroup 2: 0 placebo - 4 Vitamin D with mechloroethamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Ernst MK, Evans ST, Techner JM, Rothbaum RM, Christensen LF, Onay UV, Biyashev D, Demczuk MM, Nguyen CV, Honda KS, McCormick TS, Tsoi LC, Gudjonsson JE, Cooper KD, Lu KQ. Vitamin D3 and deconvoluting a rash. JCI Insight. 2023 Jan 24;8(2):e163789. doi: 10.1172/jci.insight.163789.

    PMID: 36692020DERIVED

MeSH Terms

Interventions

CholecalciferolAminesMechlorethamine

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Kurt Lu, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

November 17, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations

US(1)