Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Dartmouth Health

Status: Completed

Conditions: Cystic Fibrosis; Anemia, Iron-Deficiency

Treatments: Drug: Ferrous sulfate 325mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01755455

D11176

CPHS#22884 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Ferrous sulfate 325mg

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous sulfate 325mg

Placebo

Placebo Comparator group

Description:

Identical-appearing tablet taken by mouth daily for 6 weeks

Treatment:

Drug: Placebo