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Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920502
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : October 10, 2016
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Kurt Lu, University Hospitals Cleveland Medical Center

Brief Summary:

Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency over the last few years is to give higher, less frequent doses. Disease-specific dosing is of interest, and there may be optimal serum concentration targets based on disease process. The best evidence so far is for optimal bone health, where most experts agree that 25OHD serum concentration should be above 30 ng/ml.

There is mounting evidence that Vitamin D therapy will reduce inflammatory response and macrophage activation. The optimal dosing needed to decrease the inflammatory response is unclear, although our recent mouse model has demonstrated that a onetime high dose is effective. The investigators therefore hypothesize that a one-time high dose of cholecalciferol will be effective in suppression of macrophage production of tumor necrosis factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot study is to assess the optimum dosage for the most macrophage suppression.


Condition or disease Intervention/treatment Phase
Inflammation Dietary Supplement: Arm 2: cholecalciferol 50,000 IU Dietary Supplement: Arm 3: cholecalciferol 100,000 IU Dietary Supplement: Arm 4: cholecalciferol 200,000 IU Other: Arm 1: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages
Study Start Date : June 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Arm 1: Placebo
Normal Healthy Volunteers without any skin pathology, will receive placebo
Other: Arm 1: Placebo
One time dose of Placebo

Experimental: Arm 2: cholecalciferol: 50,000 IU
Normal healthy Volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 50,000 IU.
Dietary Supplement: Arm 2: cholecalciferol 50,000 IU
One time dose of cholecalciferol 50,000 IU

Experimental: Arm 3: cholecalciferol: 100,000 IU
Normal healthy volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 100,000 IU.
Dietary Supplement: Arm 3: cholecalciferol 100,000 IU
One time dose of cholecalciferol 100,000 IU

Experimental: Arm 4: cholecalciferol: 200,000 IU
Normal Healthy volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 200,000 IU.
Dietary Supplement: Arm 4: cholecalciferol 200,000 IU
One time dose of cholecalciferol 200,000 IU




Primary Outcome Measures :
  1. Primary Measure Assessing Change of Erythema and Edema [ Time Frame: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks ]
    MED testing & Recovery from UV-induced erythema and edema before a one time dose of cholecalciferol


Secondary Outcome Measures :
  1. Secondary Measure Assessing Change of Serum Vitamin D Levels and Skin Inflammation [ Time Frame: Before:24 hours, 48 hours, 72 hours, 1 week, 2 weeks ; After: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month ]
    Sample Analysis (from blood and skin): Skin and blood samples will be collected from all study subjects to look at serum vitamin D levels and the effect of serum 25OHD concentration on levels of pro-inflammatory factors in the skin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults ages 18 years or older
  • Fitzpatrick Skin Type I-Ill
  • In good general health and able to list all current medications and medical conditions
  • Capable of giving informed consent

Exclusion Criteria:

  • Volunteers ages 18 years or younger
  • Women who are pregnant, nursing, or who may become pregnant in the next 3 months
  • Participants taking illegal drugs
  • Chronic medical conditions
  • Currently taking statins, ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
  • Currently consuming 800 IU or more of vitamin D a day
  • Current or recent use of anti-inflammatory medications or any other medications that may cause photosensitivity, at the discretion of the Pl.

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): NCT02920502


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
University of Colorado, Denver
Investigators
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Principal Investigator: Kurt Lu, MD University Hospitals Cleveland Medical Center
Publications:
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Responsible Party: Kurt Lu, Assistant Professor, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02920502    
Other Study ID Numbers: 06-13-15
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents