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Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004361
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia.

II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.


Condition Intervention
Hypoparathyroidism Tetralogy of Fallot Pulmonary Valve Stenosis Conotruncal Cardiac Defects Heart Defects, Congenital Pulmonary Atresia Drug: calcium gluconate Drug: sodium citrate

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 150
Study Start Date: July 1995
Detailed Description:

PROTOCOL OUTLINE:

Patients are given sodium citrate over a 2 hour infusion on day 1. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion. On day 2, patients are given calcium gluconate over a 2 hour infusion. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Diagnostically shown repaired or palliated conotruncal cardiac defects, including tetralogy of Fallot with pulmonary stenosis or pulmonary atresia, truncus arteriosus, or interrupted aortic arch type B
  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): NCT00004361


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Study Chair: Craig B. Langman Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

ClinicalTrials.gov Identifier: NCT00004361     History of Changes
Other Study ID Numbers: 199/11936
NU-553
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
Last Verified: January 2001

Keywords provided by Office of Rare Diseases (ORD):
DiGeorge syndrome
cardiovascular and respiratory diseases
conotruncal cardiac defects
endocrine disorders
genetic diseases and dysmorphic syndromes
hypoparathyroidism
pulmonary valve stenosis
rare disease
tetralogy of Fallot

Additional relevant MeSH terms:
Hypoparathyroidism
Congenital Abnormalities
Heart Defects, Congenital
Tetralogy of Fallot
Pulmonary Atresia
Pulmonary Valve Stenosis
Parathyroid Diseases
Endocrine System Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Vascular Malformations
Heart Valve Diseases
Ventricular Outflow Obstruction
Calcium, Dietary
Citric Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action