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Vitamin A, Its Receptors and Asthma

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ClinicalTrials.gov Identifier: NCT00628329
Recruitment Status : Withdrawn
First Posted : March 5, 2008
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent in asthmatics and their responsiveness decreased.

Condition or disease
Asthma

Detailed Description:
We wish to define the association of asthma, vitamin A serum levels and vitamin A receptor number and responsiveness on circulating mononuclear cells. Asthma is a complex, heterogenous and often debilitating and potentially deadly disease. The causes for asthma are many, with susceptibility and resistance to treatment is poorly understood. Ultimately, looking at this disease from another angle such as the role of Vitamin A and/or receptors can help us learn more about the pathophysiology and treatment of asthma.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vitamin A, Its Receptors and Asthma: Vitamin A Levels in Serum and Expression and Responsiveness of Vitamin A Receptors in Circulating Mononuclear Cells of Asthmatics
Study Start Date : May 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin A
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
2


Outcome Measures

Primary Outcome Measures :
  1. Retinol levels in blood, flow cytometric study of the RXRRAR receptors before and after addition of ATRA, 9-cis-RA and steroid [ Time Frame: 2-4 weeks after blood sample drawn ]

Biospecimen Retention:   Samples With DNA
Serum without DNA, cells with DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male or female Age 18-64
Criteria

Inclusion Criteria:

  • Patients with previously diagnosed asthma on inhaled corticosteroids, systemic steroids and/or long acting beta agonist (for a period of 6 mo to 5 years)
  • Age 18-64
  • Male or female

Exclusion Criteria:

  • Children under age 18
  • Adults 65 or older
  • Patients with COPD
Contacts and Locations

Information from the National Library of Medicine

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): NCT00628329


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Daniel Stechschulte, MD University of Kansas Medical Center
More Information

Responsible Party: Selina Gierer, D.O., Assistant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00628329     History of Changes
Other Study ID Numbers: 11213
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Selina Gierer, D.O., University of Kansas:
asthma, retinol, cis-retinoic acid

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents