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OpenTrials
Completed

NCT Number: NCT01755455

Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases Iron Deficiencies Iron Metabolism Disorders Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center, Portland, Maine, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Ferrous sulfate 325mg

Drug

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

Placebo

Drug

Matching placebo capsule

Primary outcomes

  1. Change From Baseline in Hemoglobin Concentration (gm/dl)

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Change From Baseline in Serum Iron (mcg/dl)

    Time frame: Baseline and 6 weeks

  2. Change From Baseline in Transferrin Saturation (%)

    Time frame: Baseline and 6 weeks

  3. Change From Baseline in Sputum Iron (ng/mg)

    Time frame: Baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2012
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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