Oral Iron Supplementation in Pulmonary Hypertension
![]() |
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: NCT01446848 |
Recruitment Status :
Completed
First Posted : October 5, 2011
Last Update Posted : August 12, 2014
|
Sponsor:
The Cleveland Clinic
Information provided by (Responsible Party):
Samar Farha, MD, The Cleveland Clinic
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | October 3, 2011 | |||
First Posted Date ICMJE | October 5, 2011 | |||
Last Update Posted Date | August 12, 2014 | |||
Study Start Date ICMJE | January 2012 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
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 Iron Supplementation in Pulmonary Hypertension | |||
Official Title ICMJE | Oral Iron Supplementation in Pulmonary Hypertension | |||
Brief Summary | The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency. | |||
Detailed Description | Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Pulmonary Arterial Hypertension | |||
Intervention ICMJE | Dietary Supplement: iron supplement
325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.
Other Name: ferrous sulfate tablets
|
|||
Study Arms ICMJE | Experimental: iron supplement
open-label iron supplement intervention group
Intervention: Dietary Supplement: iron supplement
|
|||
Publications * | Not Provided | |||
* 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 |
6 | |||
Original Estimated Enrollment ICMJE |
25 | |||
Actual Study Completion Date ICMJE | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 21 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 | NCT01446848 | |||
Other Study ID Numbers ICMJE | RPC-2011-1026 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Samar Farha, MD, The Cleveland Clinic | |||
Original Responsible Party | Erika Lundgrin, The Cleveland Clinic, Principal Investigator | |||
Current Study Sponsor ICMJE | The Cleveland Clinic | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | The Cleveland Clinic | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |