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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:
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
 (submitted: October 4, 2011)
  • Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
  • Change in serum ferritin from baseline [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • Change in serum erythropoietin from baseline [ Time Frame: 3 months ]
  • Change in transferrin saturation from baseline [ Time Frame: 3 months ]
  • Change in %CD34+/133+ cells from baseline [ Time Frame: 3 months ]
  • Change in pulmonary arterial pressure from baseline [ Time Frame: 3 months ]
    estimated using echocardiogram
  • Change in six minute walk distance from baseline [ Time Frame: 3 months ]
  • NYHA/WHO classification [ Time Frame: 3 months ]
  • Side effects of iron supplementation [ Time Frame: 3 months ]
  • Deaths and hospitalizations greater than 24 hours [ Time Frame: 3 months ]
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
 (submitted: August 11, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
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:

  • age 21 and older
  • diagnosis of idiopathic pulmonary arterial hypertension
  • iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)

Exclusion Criteria:

  • active infection, malignancy, or bleeding
  • hemochromatosis
  • chronic inflammatory or autoimmune disease
  • currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
  • allergy to iron
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Samar Farha, MD The Cleveland Clinic
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