Winter 2007

CARES Foundation, Inc.

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Clinical Trials

 
The studies advertised on these pages may have appeared in previous editions of the CARES newsletter. We update the CAH studies section of the newsletter and website as studies become available. For an up-to-date list, visit http://www.caresfoundation.org/clinical_trials.html.

 

CAH Volunteers Needed for Exercise Study

 

Catecholamine Reserve and Exercise Tolerance in Subjects with Congenital Adrenal Hyperplasia

and in Healthy Controls
 

Principal Investigator: Dr. Deborah Merke M.D.Pediatric Endocrinologist and Director of Pediatric Services at the National Institutes of Health, Bethesda, Maryland
 

At the National Institutes of Health in Bethesda, Maryland, we are currently investigating the effects of high-intensity short term exercise over 20 minutes in patients with CAH. Since participation in the study does not confer immediate benefit to the volunteer, CAH participants will be paid $200 upon completion of the study. In order to participate in this study volunteers must:

  • have the non-classic form of CAH (21-hydroxylase deficiency)

  • be between 9-40 years old

  • demonstrate good clinical control defined by: 17-OH-progesterone level between 100 and 1500 ng/dl, plasma renin activity within the normal reference range, growth rate within 2 standard deviations for age, and no new signs or symptoms of virilization in females.

  • not be on other medications besides their CAH-related medications.
     

Travel is paid by the NIH.
 

For more information or to volunteer, please contact Liza Green-Golan at the NIH at (301) 496-0610. 

 

 

CAH Study at the University of North Carolina
Chapel Hill

Karen Jane Loechner, M.D./Ph.D.

We are recruiting children with CAH who are 4-12 years old (bone age <14 years), are still growing, and have not yet started puberty. Children will be enrolled in the study at the General Clinical Research Center at the University of North Carolina, Chapel Hill.

Although cortisol replacement (hydrocortisone, prednisone, or dexamethasone, for example) and Florinef have virtually eliminated mortality, there are at least two reasons for continuing to try to perfect our treatment regimens: (1) the linear growth of children is suboptimal and the end result is an adult who is too short, and (2) overtreatment with glucocorticoids in children may increase risk of osteoporosis in later years.

Based on studies of the regulation of release of ACTH (that, in turn, drives the production of hormones from the adrenal cortex), we have found that we can decrease the amount of ACTH using calcium channel blockers (medications typically used to treat high blood pressure, such as amlodipine). Amlodipine has been shown to be safe even in infants treated for a variety of medical reasons.

Our hypothesis is that addition of amlodipine will allow us to decrease the amount of glucocorticoid medication that your child is currently taking to control his/her CAH. Such a decrease should translate into better growth and bone strength. This new medication would be added to your child’s current CAH treatment program and evaluated in a double-blind/placebo-controlled crossover study.

For more information, please contact Dr. Karen Loechner at (919) 216-5946 (pager) or (919) 966-4435 ext. 224 (voice mail); fax (919) 966-2423; Roxanne Schock, CDE, Clinical Coordinator at (919) 966-0428 (voice mail). All visits, including laboratory testing, research medication, and parking will be paid for by this protocol. Limited “off-site” testing at your local care provider may be available subject to IRB approval. Travel funds available (please inquire for details).

 

     

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