Oral Nifedipine to Treat Iron Overload
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ClinicalTrials.gov Identifier: NCT00712738 |
Recruitment Status :
Completed
First Posted : July 10, 2008
Last Update Posted : July 2, 2017
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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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Condition or disease | Intervention/treatment | Phase |
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Thalassemia Iron Overload Hemochromatosis | Drug: Nifedipine Procedure: Phlebotomy Procedure: Urinalysis Procedure: Echocardiogram Procedure: Electrocardiogram | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Trial of Oral Nifedipine for the Treatment of Iron Overload |
Study Start Date : | June 20, 2008 |
Actual Primary Completion Date : | September 22, 2010 |
Actual Study Completion Date : | September 22, 2010 |

- Evaluate nifedipine-related urinary iron excretion.
- Evaluate potential for nifedipine to increase urinary iron excretion among patients with iron overload.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712738
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | Jeffery L. Miller, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health |
ClinicalTrials.gov Identifier: | NCT00712738 |
Other Study ID Numbers: |
080157 08-DK-0157 |
First Posted: | July 10, 2008 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | September 22, 2010 |
Nifedipine Thalassemia Hemochromatosis Iron Overload Iron Excretion |
Thalassemia Hemochromatosis Iron Overload Hemosiderosis Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Iron Metabolism Disorders Metabolic Diseases |
Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Nifedipine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |