NCT00227058

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 23, 2005

Last Update Submit

January 24, 2007

Conditions

Seasonal Allergic Rhinitis

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Improvement in nasal symptom scores from baseline after intervention

Secondary Outcomes (1)

  • change in cytokine profile with intervention compared to placebo

Interventions

Orotic acid and Glutathione-(Nutritional Supplements)DRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic

Interventions

Orotic Acid

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Acids, HeterocyclicHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Gailen D. Marshall, MD/PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

January 1, 2005

Study Completion

November 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

US(1)