NCT01446848

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

October 3, 2011

Last Update Submit

August 11, 2014

Conditions

Pulmonary Arterial Hypertension

Keywords

iron deficiencypulmonary hypertensioniron supplementsferrous sulfate

Outcome Measures

Primary Outcomes (2)

  • Change in Zinc protoporphyrin from baseline

    3 months

  • Change in serum ferritin from baseline

    3 months

Secondary Outcomes (8)

  • Change in serum erythropoietin from baseline

    3 months

  • Change in transferrin saturation from baseline

    3 months

  • Change in %CD34+/133+ cells from baseline

    3 months

  • Change in pulmonary arterial pressure from baseline

    3 months

  • Change in six minute walk distance from baseline

    3 months

  • +3 more secondary outcomes

Study Arms (1)

iron supplement

EXPERIMENTAL

open-label iron supplement intervention group

Dietary Supplement: iron supplement

Interventions

iron supplementDIETARY_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.

Also known as: ferrous sulfate tablets
iron supplement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • active infection, malignancy, or bleeding
  • hemochromatosis
  • chronic inflammatory or autoimmune disease
  • currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
  • allergy to iron

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionIron DeficienciesHypertension, Pulmonary

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Samar Farha, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Pulmonologist

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

US(1)