NCT01755455

Brief Summary

This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

March 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

December 19, 2012

Results QC Date

December 31, 2013

Last Update Submit

February 7, 2017

Conditions

Cystic FibrosisAnemia, Iron-Deficiency

Keywords

Cystic fibrosisIronHepcidinAnemiaErythropoiesis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hemoglobin Concentration (gm/dl)

    Baseline and 6 weeks

Secondary Outcomes (3)

  • Change From Baseline in Serum Iron (mcg/dl)

    Baseline and 6 weeks

  • Change From Baseline in Transferrin Saturation (%)

    Baseline and 6 weeks

  • Change From Baseline in Sputum Iron (ng/mg)

    Baseline and 6 weeks

Study Arms (2)

Ferrous sulfate 325mg

ACTIVE COMPARATOR

Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks

Drug: Ferrous sulfate 325mg

Placebo

PLACEBO COMPARATOR

Identical-appearing tablet taken by mouth daily for 6 weeks

Drug: Placebo

Interventions

Ferrous sulfate 325mgDRUG

Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks

Ferrous sulfate 325mg
PlaceboDRUG

Matching placebo capsule

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of Pseudomonas aeruginosa colonization of the lung
  • Transferrin saturation (TSAT) less than or equal to 21%
  • Hemoglobin concentration \<15.5 gm/dl (men)
  • Hemoglobin concentration \<13.6 gm/dl (women)

You may not qualify if:

  • Use of iron-containing vitamin or supplement
  • Pregnancy
  • Lactation
  • Cirrhosis
  • History of chronic visible (gross) hemoptysis
  • Hereditary hemochromatosis
  • History of transfusion-related iron overload
  • Use of iron chelator(s)
  • Withdrawal of informed consent
  • Contraindication to phlebotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Gifford AH, Alexandru DM, Li Z, Dorman DB, Moulton LA, Price KE, Hampton TH, Sogin ML, Zuckerman JB, Parker HW, Stanton BA, O'Toole GA. Iron supplementation does not worsen respiratory health or alter the sputum microbiome in cystic fibrosis. J Cyst Fibros. 2014 May;13(3):311-8. doi: 10.1016/j.jcf.2013.11.004. Epub 2013 Dec 13.

    PMID: 24332997RESULT

Related Links

MeSH Terms

Conditions

Cystic FibrosisAnemia, Iron-DeficiencyAnemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesAnemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

The power to detect changes in Akron PES was 42%; 160 subjects would be needed to ensure that exacerbation risk was lower for ferrous sulfate with 80% power and p \<0.05.

Results Point of Contact

Title
Alex H. Gifford, M.D.
Organization
Dartmouth-Hitchcock Medical Center
alex.h.gifford@hitchcock.org
603-650-5533

Study Officials

  • Alex H Gifford, M.D.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

June 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 16, 2017

Results First Posted

October 6, 2014

Record last verified: 2017-02

Locations

US(2)