Trial Outcomes & Findings for Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis (NCT NCT01755455)

NCT ID: NCT01755455

Last Updated: 2017-03-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline and 6 weeks
• Results posted on: 2017-03-16

Participant Flow

Participant milestones

Measure	Placebo, Then Ferrous Sulfate Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.	Ferrous Sulfate, Then Placebo Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
First Intervention (6 Weeks) STARTED	11	11
First Intervention (6 Weeks) COMPLETED	11	11
First Intervention (6 Weeks) NOT COMPLETED	0	0
Washout (4 Weeks) STARTED	11	11
Washout (4 Weeks) COMPLETED	11	11
Washout (4 Weeks) NOT COMPLETED	0	0
Second Intervention (6 Weeks) STARTED	11	11
Second Intervention (6 Weeks) COMPLETED	11	11
Second Intervention (6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Baseline characteristics by cohort

Measure	All Study Participants n=22 Participants Includes those who started the study with First Intervention and those who started the study with Second Intervention
Age, Continuous	32.1 years STANDARD_DEVIATION 13.6 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Outcome measures

Measure	Placebo n=22 Participants Outcome measure in all participants who received placebo.	Ferrous Sulfate n=22 Participants Outcome measure in all participants who received ferrous sulfate.
Change From Baseline in Hemoglobin Concentration (gm/dl)	0.12 gm/dl Standard Error 0.13	0.09 gm/dl Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Outcome measures

Measure	Placebo n=22 Participants Outcome measure in all participants who received placebo.	Ferrous Sulfate n=22 Participants Outcome measure in all participants who received ferrous sulfate.
Change From Baseline in Serum Iron (mcg/dl)	13.7 mcg/dl Standard Error 5.9	-4.2 mcg/dl Standard Error 5.7

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Outcome measures

Measure	Placebo n=22 Participants Outcome measure in all participants who received placebo.	Ferrous Sulfate n=22 Participants Outcome measure in all participants who received ferrous sulfate.
Change From Baseline in Transferrin Saturation (%)	4.7 % saturation Standard Error 1.5	-1.8 % saturation Standard Error 1.7

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Outcome measures

Measure	Placebo n=22 Participants Outcome measure in all participants who received placebo.	Ferrous Sulfate n=22 Participants Outcome measure in all participants who received ferrous sulfate.
Change From Baseline in Sputum Iron (ng/mg)	0.13 ng/mg Standard Error 0.17	0.42 ng/mg Standard Error 0.21

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Ferrous Sulfate

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=22 participants at risk Events observed among all participants while they were receiving placebo.	Ferrous Sulfate n=22 participants at risk Events observed among all participants while they were receiving ferrous sulfate.
Gastrointestinal disorders Constipation	18.2% 4/22 • Number of events 5 • 6 weeks	13.6% 3/22 • Number of events 3 • 6 weeks

Other adverse events

Measure	Placebo n=22 participants at risk Events observed among all participants while they were receiving placebo.	Ferrous Sulfate n=22 participants at risk Events observed among all participants while they were receiving ferrous sulfate.
Respiratory, thoracic and mediastinal disorders Pulmonary Exacerbation	59.1% 13/22 • Number of events 19 • 6 weeks	50.0% 11/22 • Number of events 14 • 6 weeks

Additional Information

Alex H. Gifford, M.D.

Dartmouth-Hitchcock Medical Center

Phone: 603-650-5533

Email: alex.h.gifford@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place