Status:
TERMINATED
Clinical and Laboratory Investigation of Humans With Informative Iron or Erythroid Phenotypes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hemoglobinopathies
Hemolysis
Eligibility:
All Genders
1+ years
Brief Summary
This study will examine blood for factors that may cause or prevent diseases involving iron or red blood cells. Iron is an important nutrient for human health that is needed to produce red blood cells...
Detailed Description
Studies of iron and erythroid cells, have provided fundamental insights into structure function relationships of proteins, energy metabolism, and the molecular basis of many diseases. Based upon the i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A clinically definable iron or erythroid cell phenotype as defined by:
- Group 1: Patients with known iron or erythroid diseases (examples: iron deficient anemia or ineffective erythropoiesis).
- OR
- Group 2: Patients with diseases of unknown etiology (example: unexplained iron overload or anemia).
- OR
- Group 3: Patients with an informative phenotype in the absence of overt clinical disease (example: hereditary persistence of fetal hemoglobin).
- OR
- Group 4: Healthy volunteers whose blood or bone marrow samples will be utilized to understand normal iron and erythroid biology and for comparison with the other groups described above.
- AGE AND GENDER CONSIDERATIONS:
- Age range: Infancy to unlimited
- Adults: Adults who fall into Groups 1-4 are eligible to enroll in this protocol. They must possess the ability to comprehend the investigational nature of the study and provide informed consent.
- Minors: Minors who fall into groups 1-4 are eligible to enroll in the study for collection of research blood. Within Group 4 (healthy volunteers, minors), the research will not involve greater than minimal risk.
- GENERAL EXCLUSION CRITERIA:
- Healthy volunteers and Subjects with iron or erythroid diseases who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.
- INCLUSION AND EXCLUSION CRITERIA FOR BONE MARROW SAMPLING:
- With the exception of minors, pregnant females, and breast-feeding mothers, volunteers who meet the General Inclusion Criteria for blood collection may be offered the option of bone marrow sampling as part of this protocol. Minors, pregnant females, and breastfeeding mothers will be excluded from bone marrow sampling specifically performed for this protocol. However, they will be asked to consent for collection of up to an additional sample of bone marrow if 1) they are undergoing a bone marrow sampling procedure for clinical purposes, and 2) collection of the additional bone marrow undergoing a clinical procedure if the research sample collection doesn t alter the clinical procedure.
- Other bone marrow sampling exclusion criteria include: 1) allergy to xylocaine (lidocaine) or the skin cleansing medication chlorhexidine/Hibiclens. 2) clotting disorders, low platelets (\<50,000k) or are taking medications that interfere with blood clotting, such as aspirin, non-steroidal anti-inflammatory agents (such as Motrin or Advil) or blood thinning agents (such as coumadin/warfarin).
Exclusion
Key Trial Info
Start Date :
January 18 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2017
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00102245
Start Date
January 18 2005
End Date
August 4 2017
Last Update
February 14 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892