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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

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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)

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






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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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
Tetralogy of Fallot
Heart Defects, Congenital
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