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:

Collaborator:

Ann & Robert H Lurie Children's Hospital of Chicago

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004361

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: January 2001

History of Changes

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:

Genetics Home Reference related topics: Parkes Weber syndrome capillary malformation-arteriovenous malformation syndrome

MedlinePlus related topics: Calcium

Drug Information available for: Calcium Gluconate Sodium citrate

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

U.S. FDA Resources

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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 Constriction, Pathologic Congenital Abnormalities Heart Defects, Congenital Tetralogy of Fallot Pulmonary Atresia Pulmonary Valve Stenosis Pathological Conditions, Anatomical Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Parathyroid Diseases Endocrine System 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

ClinicalTrials.gov processed this record on September 29, 2016

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