CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02258997
NCT02258997N/ACompleted

Hepcidin Levels in Sickle Cell Disease (SCD)

Kenneth Ataga, MD·observational·Posted Oct 8, 2014·Updated Oct 8, 2015

In Brief

An observational study for Sickle Cell Anemia and Sickle - Beta Thalassemia. Completed, enrolled 42 participants.

Detailed Summary

The investigators propose that patients with HbSβ-thalassemia have lower levels of hepcidin and higher levels of GDF-15 than HbSS patients during the non-crisis, "steady states." In addition, the investigators propose that when controlled for RBC transfusion, patients with HbSβ-thalassemia will have higher levels of storage iron (based on serum ferritin). Participants: Total number of subjects is 42 - 21 subjects with HbSS, and 21 subjects with HbSβ-thalassemia ). Procedures (methods): Eligible subjects with documented SCD (HbSS, HbS-β 0-thalassemia or HbS-β+-thalassemia) followed at the University of North Carolina (UNC) Comprehensive Sickle Cell Program will be evaluated in this single-center, prospective, cross-sectional study. The patients will be screened for eligibility at the time of a routine sickle cell clinic visit. Patients' data will be obtained in person at the time of evaluation and through review of their medical records. Investigators will obtain information on SCD-related clinical complications and obtain an estimate of the number of lifetime RBC transfusions. Blood samples will be obtained for laboratory tests. Plasma samples for hepcidin, growth differentiation factor 15 (GDF -15), and high-sensitivity CRP will be stored at -80 degrees Celsius until analysis. Other routine laboratory studies including complete blood count (CBC) with differential and reticulocyte count, serum iron profile and ferritin, and liver function tests will be performed at the clinical laboratories of UNC Hospitals.The subjects will have 30 ml. of blood drawn for this research study. Females of child bearing potential will have a urine pregnancy test at the time of the study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsAugusta University

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2014
Enrollment StartMar 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.7 years ago