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

Completed · Phase 3 · Has a placebo group

Conditions studied: Inflammation

In brief

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.

Key facts

Study ID

NCT02920502

Run by

University Hospitals Cleveland Medical Center

People needed

24

Starts

2013-06-01

Expected to finish

2015-08-01

Last updated by the study team

2016-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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