- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004361
Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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 Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Craig B. Langman, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Endocrine System Diseases
- Parathyroid Diseases
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Cardiovascular Abnormalities
- Vascular Malformations
- Congenital Abnormalities
- Tetralogy of Fallot
- Heart Defects, Congenital
- Pulmonary Valve Stenosis
- Hypoparathyroidism
- Pulmonary Atresia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Calcium-Regulating Hormones and Agents
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Calcium
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- 199/11936
- NU-553
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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