- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00712738
Oral Nifedipine to Treat Iron Overload
A Trial of Oral Nifedipine for the Treatment of Iron Overload
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 by the body's inability to regulate iron or by medical treatments, such as multiple blood transfusions. Over time, it can cause problems with the liver, heart and glands. Treatments include reducing iron intake in the diet or removing the excess iron using medical therapies. Recently, nifedipine was found to cause iron loss in the urine of small animals. This study will see if the drug can increase the removal of iron into the urine in humans as well.
People 18 years of age and older with iron overload may be eligible for this study to undergo the following procedures:
Study Day 1
Participants come to the NIH Clinical Center for a medical history, physical examination, blood and urine tests, electrocardiogram (EKG) and echocardiogram (heart ultrasound).
Study Day 2
Participants will collect three urine samples: one is collected over 4 hours, followed by a second over 4 hours. Both of these samples are collected at NIH in the outpatient day hospital. At home, a third urine sample will be collected over 16 hours. For 1 week before the collections, participants are asked not to drink tea or eat foods high in Vitamin C or iron. They are also asked not to take any iron chelating medications.
Study Day 3
Participants repeat the same urine collections as on day 2. They collect a 4-hour urine sample at the outpatient day hospital at NIH. They will then take a 20-mg tablet of nifedipine, and remain in the clinic 4 hours for blood pressure monitoring. A second urine sample during this time. They then return home to collect the final 16-hour sample, which they bring to the clinic the following day. Again, they are instructed to avoid a diet high in vitamin C, iron rich foods, tea, and to avoid taking any iron chelating medications.
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Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluate nifedipine-related urinary iron excretion.
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Secondary Outcome Measures
Outcome Measure |
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Evaluate potential for nifedipine to increase urinary iron excretion among patients with iron overload.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Cappellini MD, Cohen A, Piga A, Bejaoui M, Perrotta S, Agaoglu L, Aydinok Y, Kattamis A, Kilinc Y, Porter J, Capra M, Galanello R, Fattoum S, Drelichman G, Magnano C, Verissimo M, Athanassiou-Metaxa M, Giardina P, Kourakli-Symeonidis A, Janka-Schaub G, Coates T, Vermylen C, Olivieri N, Thuret I, Opitz H, Ressayre-Djaffer C, Marks P, Alberti D. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. Blood. 2006 May 1;107(9):3455-62. doi: 10.1182/blood-2005-08-3430. Epub 2005 Dec 13.
- Barton JC. Chelation therapy for iron overload. Curr Gastroenterol Rep. 2007 Mar;9(1):74-82. doi: 10.1007/s11894-008-0024-9.
- Ludwiczek S, Theurl I, Muckenthaler MU, Jakab M, Mair SM, Theurl M, Kiss J, Paulmichl M, Hentze MW, Ritter M, Weiss G. Ca2+ channel blockers reverse iron overload by a new mechanism via divalent metal transporter-1. Nat Med. 2007 Apr;13(4):448-54. doi: 10.1038/nm1542. Epub 2007 Feb 11.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Iron Metabolism Disorders
- Metabolism, Inborn Errors
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Metal Metabolism, Inborn Errors
- Iron Overload
- Thalassemia
- Hemochromatosis
- Hemosiderosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- 080157
- 08-DK-0157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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