Oral Iron Supplementation in Pulmonary Hypertension

NeuroTherapia, Inc.

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Dietary Supplement: iron supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01446848

RPC-2011-1026

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

iron supplement

Experimental group

Description:

open-label iron supplement intervention group

Treatment:

Dietary Supplement: iron supplement