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

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ClinicalTrials.gov Identifier: NCT00004361

Recruitment Status : Completed

First Posted : October 19, 1999

Last Update Posted : June 24, 2005

Sponsor:

Collaborator:

Ann & Robert H Lurie Children's Hospital of Chicago

Information provided by:

Office of Rare Diseases (ORD)

Study Description

Brief Summary:

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

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.

Study Design


Study Type :	Observational
Enrollment :	150 participants
Primary Purpose:	Screening
Study Start Date :	July 1995

Resource links provided by the National Library of Medicine

Drug Information available for: Calcium Gluconate

Genetic and Rare Diseases Information Center resources: Tetralogy of Fallot Hypoparathyroidism 22q11.2 Deletion Syndrome Pulmonary Valve Stenosis Pulmonic Stenosis Conotruncal Heart Malformations

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

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 Posted:	October 19, 1999 Key Record Dates
Last Update Posted:	June 24, 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

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