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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 - Article


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Fallot's Tetralogy


Clinical Trial: 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.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Children's Memorial Hospital, 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 Treatment or Intervention
Hypoparathyroidism
Tetralogy of Fallot
Pulmonary Valve Stenosis
Conotruncal Cardiac Defects
Heart Defects, Congenital
Pulmonary Atresia
 Drug: calcium gluconate
 Drug: sodium citrate

MedlinePlus related topics:  Birth Defects;   Congenital Heart Disease;   Heart Diseases;   Heart Valve Diseases;   Parathyroid Disorders;   Vascular Diseases

Study Type: Observational
Study Design: Screening

Further Study Details: 

Expected Total Enrollment:  150

Study start: July 1995

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 above,  Genders Eligible for Study:  Both

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

Location Information

Study chairs or principal investigators

Craig B. Langman,  Study Chair,  Children's Memorial Hospital, Chicago   

More Information

Study ID Numbers:  199/11936; NU-553
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004361
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 13, 2008



Page Updated: September 6, 2005
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