Back to resultsStudy of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
Primary Purpose
Hypoparathyroidism, Tetralogy of Fallot, Pulmonary Valve Stenosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
calcium gluconate
sodium citrate
Sponsored by
About this trial
This is an observational trial for Hypoparathyroidism focused on measuring 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
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004361
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00004361
Brief Title
Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
Study Type
Observational
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism, Tetralogy of Fallot, Pulmonary Valve Stenosis, Conotruncal Cardiac Defects, Heart Defects, Congenital, Pulmonary Atresia
Keywords
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
7. Study Design
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
calcium gluconate
Intervention Type
Drug
Intervention Name(s)
sodium citrate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig B. Langman
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
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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