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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Dietary Supplement: iron supplement

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Iron Supplementation in Pulmonary Hypertension
Study Start Date : January 2012
Primary Completion Date : August 2014
Study Completion Date : August 2014

Arms and Interventions

Arm Intervention/treatment
Experimental: iron supplement
open-label iron supplement intervention group
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
  2. Change in serum ferritin from baseline [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in serum erythropoietin from baseline [ Time Frame: 3 months ]
  2. Change in transferrin saturation from baseline [ Time Frame: 3 months ]
  3. Change in %CD34+/133+ cells from baseline [ Time Frame: 3 months ]
  4. Change in pulmonary arterial pressure from baseline [ Time Frame: 3 months ]
    estimated using echocardiogram

  5. Change in six minute walk distance from baseline [ Time Frame: 3 months ]
  6. NYHA/WHO classification [ Time Frame: 3 months ]
  7. Side effects of iron supplementation [ Time Frame: 3 months ]
  8. Deaths and hospitalizations greater than 24 hours [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01446848

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Samar Farha, MD The Cleveland Clinic
More Information

Responsible Party: Samar Farha, MD, Staff Pulmonologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01446848     History of Changes
Other Study ID Numbers: RPC-2011-1026
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by Samar Farha, MD, The Cleveland Clinic:
iron deficiency
pulmonary hypertension
iron supplements
ferrous sulfate

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs