Status:
COMPLETED
Oral Nifedipine to Treat Iron Overload
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thalassemia
Iron Overload
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine if nifedipine, a medication used to treat high blood pressure, can help treat iron overload, a condition in which the body contains too much iron. Iron overload can be caused...
Detailed Description
Iron overload is common worldwide. If left untreated, body iron overload leads to multiple organ abnormalities including hepatic, endocrine (diabetes) and cardiac failure. In patients with ineffective...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Iron overloaded subjects will have a history of iron overload that may be due to a variety of causes including genetic hemochromatosis or thalassemia or other transfusion-dependent anemias (e.g. sickle cell syndromes, aplastic anemia, ineffective erythropoiesis) or other causes. Entry into the study requires that all subjects possess at least minimal evidence of iron overload at the time of entry (defined as serum ferritin and serum transferrin saturations levels above the normal range). Among fifty (50) subjects recruited for this protocol, at least twenty (20) with significant iron overload (defined in this study as ferritin greater than 500 ng/ml and transferrin saturation greater than (50%) will be included.
- All subjects will be of adult age (greater than or equal to 18 yrs).
- All subjects enrolled in this protocol will have a primary physician and care in the community that is capable of managing any medical problems unrelated to the nifedipine regimen.
- All subjects must be able to provide informed consent.
- EXCLUSION CRITERIA:
- Allergy to nifedipine.
- Patient receiving calcium channel blocker therapy within 7 days prior to enrollment.
- Blood transfusion within 7 days of first urine iron evaluation.
- Pregnant or lactating women.
- Patients with GFR less than 60 ml/min.
- Albumin less than 3g/dl.
- Significant hemoglobinuria (greater than1+ on urinalysis).
- Hemoglobin less than 10 g/dl
- Uncompensated cardiac disease including decreased ejection fraction detected by echocardiogram, angina, hypotension (less than 90mmHg systolic pressure) or symptomatic arrhythmias. Documented myocardial infarction within one year prior to the study.
- Use of tea, Vitamin C, iron chelation therapy, iron supplements, grapefruit juice, cimetidine, digitalis, quinidine, or beta-blockers (due to potential for increased serum drug levels versus cardiovascular risk) within 7 days prior to the study.
Exclusion
Key Trial Info
Start Date :
June 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00712738
Start Date
June 20 2008
End Date
September 22 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892