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NCT00004361 Clinical Trial

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

Heart Defects, Congenital Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004361
Other study ID # 199/11936
Secondary ID NU-553
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date July 1995

Study information
Verified date January 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• calcium gluconate

• sodium citrate

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Ann & Robert H Lurie Children's Hospital of Chicago
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