Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages
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|ClinicalTrials.gov Identifier: NCT02920502|
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : October 10, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 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 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.
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
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Kurt Lu, MD||University Hospitals Cleveland Medical Center|