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Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189124
First Posted: September 16, 2005
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Wendy Marder, University of Michigan
  Purpose

The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring:

  1. changes in brachial artery flow-mediated dilatation (FMD) and
  2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period.

HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.


Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Dehydroepiandrosterone (DHEA) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?

Resource links provided by NLM:


Further study details as provided by Wendy Marder, University of Michigan:

Primary Outcome Measures:
  • Brachial artery reactivity, by flow mediated dilatation

Secondary Outcome Measures:
  • Changes in biomarkers of SLE
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

Enrollment: 13
Study Start Date: September 2003
Study Completion Date: July 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Member of the Michigan Lupus Cohort
  • Meet the American College of Rheumatology (ACR) criteria for SLE
  • Premenopausal

Exclusion Criteria:

  • Smoker
  • Diabetic
  • Prednisone dose > 10 mg
  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): NCT00189124


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Arthritis Foundation
Investigators
Principal Investigator: Wendy Marder, MD University of Michigan
  More Information

Responsible Party: Wendy Marder, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00189124     History of Changes
Other Study ID Numbers: 2001-0822
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Wendy Marder, University of Michigan:
Systemic Lupus Erythematosus
Dehydroepiandrosterone (DHEA)
DHEA
SLE
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs