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

Completed

• Conditions: Hypoparathyroidism; Tetralogy of Fallot; Pulmonary Valve Stenosis; Conotruncal Cardiac Defects; Heart Defects, Congenital; Pulmonary Atresia

• Registration Number: NCT00004361
• Lead Sponsor: National Center for Research Resources (NCRR)

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.

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 Timeline

• Study Start: 1995-07
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2001-01
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified