Viewing Study NCT00001455



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001455
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Iron Overload in African Americans
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Iron Overload in African Americans
Status: COMPLETED
Status Verified Date: 1999-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Iron overload hemochromatosis is a condition which causes the intestines to take too much iron into the body from food or pills The extra iron can build up in the liver heart joints pancreas sex organs and other organs Patients with iron overload can feel well initially but the iron will eventually damage organs and may lead to an early death The condition is believed to be passed down from generation to generation Many studies have been conducted on the condition as it affects Caucasian Americans few have addressed the condition in African Americans

Researchers believe it is important to find out as much as possible about the iron overload in African Americans The goal of this study is to determine the pattern of inheritance of primary iron overload in African American families and to identify the genetic defect causing the condition

The study will use various tests from simple blood testing transferritin saturation and serum ferritin levels to complex genetic tests segregation analysis and polymerase chain reaction PCR The tests will help researchers deterimine iron levels in the blood presence of antigens that may help trace inheritance and detect changes in genes that are known to cause iron overload in Caucasians

The study may not directly benefit the patients participating in it However this study may lead to improved methods to diagnose iron overload in the African American population as a whole
Detailed Description: The purpose of this project is to determine the pattern of inheritance of primary iron overload in African American families and to identify the genetic defect The iron status of index subjects and family members will be determined by measuring transferrin saturation and serum ferritin and the genetic pattern will be studied with segregation analysis The chromosomal localization of the iron-loading locus will be pursued by determining HLA haplotypes by testing for HFE gene mutations by sequencing portions of genes for molecules involved in iron metabolism by analyzing polymorphisms in these genes by PCR by employing molecular methods to screen the genome and by testing for linkage to iron phenotype with lod scores Loci for proteins important in iron metabolism will be examined as candidate genes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
95-CH-0142 None None None