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.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Children's Memorial Hospital
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004361

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:	Screening

Resource links provided by NLM:

Genetics Home Reference related topics: 22q11.2 deletion syndrome

MedlinePlus related topics: Calcium Congenital Heart Defects

Drug Information available for: Citric acid Calcium gluconate Sodium Citrate

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004361

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Children's Memorial Hospital

Investigators

Study Chair:

Craig B. Langman

Children's Memorial Hospital

More Information

No publications provided

Study ID Numbers:	199/11936, NU-553
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004361 History of Changes
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:

Parathyroid Diseases
Pulmonary Atresia
Anticoagulants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiovascular Abnormalities
Hematologic Agents
Citric Acid
Endocrine System Diseases
Pharmacologic Actions
Heart Valve Diseases

Pulmonary Valve Stenosis
Therapeutic Uses
Vascular Malformations
Tetralogy of Fallot
Cardiovascular Diseases
Chelating Agents
Hypoparathyroidism
Congenital Abnormalities
Heart Defects, Congenital
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on February 08, 2010