Trials / Completed
CompletedNCT00004361
Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Hypoparathyroidism
- Tetralogy of Fallot
- Pulmonary Valve Stenosis
- Conotruncal Cardiac Defects
- Heart Defects, Congenital
- Pulmonary Atresia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | calcium gluconate | |
| DRUG | sodium citrate |
Timeline
- Start date
- 1995-07-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004361. Inclusion in this directory is not an endorsement.