Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Nifedipine to Treat Iron Overload

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712738
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE July 9, 2008
First Posted Date  ICMJE July 10, 2008
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE June 20, 2008
Actual Primary Completion Date September 22, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
Evaluate nifedipine-related urinary iron excretion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
Evaluate potential for nifedipine to increase urinary iron excretion among patients with iron overload.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Nifedipine to Treat Iron Overload
Official Title  ICMJE A Trial of Oral Nifedipine for the Treatment of Iron Overload
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 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.

...

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 erythropoiesis, iron overload results from the combination of increased intestinal absorption and transfusion. Unfortunately, physiological means to remove excess iron are limited, and treatments are limited to therapeutic phlebotomy and chelation therapy. While phlebotomy is the preferred therapy for patients with hemochromatosis, therapy for anemic patients is largely limited to chelation drugs. Since those drugs are frequently inadequate, additional iron-reduction therapies are being sought. Based upon recently published data in a rodent model, the purpose of this study is to determine if nifedipine will increase iron excretion in the urine among humans with increased levels of iron. Volunteers will be given a single oral dose (20mg) of nifedipine. Iron level in collections of urine will be measured and compared before and after nifedipine to determine if there is an associated increase in urinary iron excretion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thalassemia
  • Iron Overload
  • Hemochromatosis
Intervention  ICMJE
  • Drug: Nifedipine
  • Procedure: Phlebotomy
  • Procedure: Urinalysis
  • Procedure: Echocardiogram
  • Procedure: Electrocardiogram
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2010)
6
Original Enrollment  ICMJE
 (submitted: July 9, 2008)
50
Actual Study Completion Date  ICMJE September 22, 2010
Actual Primary Completion Date September 22, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712738
Other Study ID Numbers  ICMJE 080157
08-DK-0157
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffery L. Miller, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 22, 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP