Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis

January 24, 2007 updated by: University of Mississippi Medical Center

Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic

The purpose of this study is to learn if two nutritional supplements, Orotic Acid and Glutathione will have any effect on the immune system response and if there will be any effect on the symptoms of seasonal allergies. It is our thinking that they will have an positive effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current therapy for most immune-based diseases center around the use of anti inflammatory agents, many of which have unpleasant or dangerous side effects. Allergic rhinitis affects over 40 million Americans and its morbidity results from a combination of physical and psychological symptoms. The primary immunopathology has been defined as an imbalance of TH1/TH2 cytokines production resulting in increased allergen-specific IgE production, mast cell activation and eosinophil recruitment/activity. Metallic salts of orotic acid (OR), a natural intermediate in pyrimidine nucleic acid synthesis have been utilized to improve the signs and symptoms of a variety of maladies including the common cold, allergies and as preventatives for cancer and heart disease. Recent studies have reported that moderate doses of OR can mitigate or prevent endocrine and subjective psychological stresses in an acute laboratory stress model. All these findings lead us to hypothesize that OR salts administration will alleviate or eliminate the signs and symptoms associated with seasonal AR through a protective effect that involves direct anti-inflammatory immune effects and/or immunomodulation that include leukocyte trafficking, immunoregulatory cytokine balance and/or decrease inflammatory cell activity.

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Participants must have allergic rhinitis and be skin test positive to Bermuda Grass, Johnson grass, oak tree and/or ragweed, be symptomatic -

Exclusion Criteria: Any significant known heath disease: cardiovascular disease, cancer, or any metabolic disorder, smoker

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in nasal symptom scores from baseline after intervention

Secondary Outcome Measures

Outcome Measure
change in cytokine profile with intervention compared to placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Collaborators

Kyowa Hakko Kogyo Co., Ltd.

Investigators

  • Principal Investigator: Gailen D. Marshall, MD/PhD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

January 26, 2007

Last Update Submitted That Met QC Criteria

January 24, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHK040213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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