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

NCT02920502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-10-10

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Arm 2: cholecalciferol 50,000 IU

One time dose of cholecalciferol 50,000 IU

DIETARY_SUPPLEMENT

Arm 3: cholecalciferol 100,000 IU

One time dose of cholecalciferol 100,000 IU

DIETARY_SUPPLEMENT

Arm 4: cholecalciferol 200,000 IU

One time dose of cholecalciferol 200,000 IU

OTHER

Arm 1: Placebo

One time dose of Placebo

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Kurt Lu, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920502 on ClinicalTrials.gov