NCT00004361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2001

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

HypoparathyroidismTetralogy of FallotPulmonary Valve StenosisConotruncal Cardiac DefectsHeart Defects, CongenitalPulmonary Atresia

Keywords

DiGeorge syndromecardiovascular and respiratory diseasesconotruncal cardiac defectsendocrine disordersgenetic diseases and dysmorphic syndromeshypoparathyroidismpulmonary valve stenosisrare diseasetetralogy of Fallot

Interventions

calcium gluconateDRUG
sodium citrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

HypoparathyroidismTetralogy of FallotPulmonary Valve StenosisConotruncal cardiac defectsHeart Defects, CongenitalPulmonary AtresiaDiGeorge SyndromeRespiratory Tract DiseasesEndocrine System DiseasesGenetic Diseases, InbornRare Diseases

Interventions

Calcium GluconateSodium Citrate

Condition Hierarchy (Ancestors)

Parathyroid DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Valve DiseasesVentricular Outflow ObstructionVascular Malformations22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleChromosome DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCitric AcidCitratesTricarboxylic Acids

Study Officials

  • Craig B. Langman

    Ann & Robert H Lurie Children's Hospital of Chicago

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

July 1, 1995

Last Updated

June 24, 2005

Record last verified: 2001-01