Oral Iron Supplementation in Pulmonary Hypertension
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ClinicalTrials.gov Identifier: NCT01446848 |
Recruitment Status :
Completed
First Posted : October 5, 2011
Last Update Posted : August 12, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Dietary Supplement: iron supplement | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: iron supplement
open-label iron supplement intervention group
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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 |
- Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
- Change in serum ferritin from baseline [ Time Frame: 3 months ]
- 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 ]

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
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

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 |
Principal Investigator: | Samar Farha, MD | The Cleveland Clinic |
Responsible Party: | Samar Farha, MD, Staff Pulmonologist, The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT01446848 |
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 |
iron deficiency pulmonary hypertension iron supplements ferrous sulfate |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |