Cystic FibrosisNCT01755455
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
A study testing Ferrous sulfate 325mg in people with Cystic Fibrosis and Anemia, Iron-Deficiency, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Anemia, Iron-Deficiency
- What is being tested?
- Ferrous sulfate 325mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Use of iron-containing vitamin or supplement
- Pregnancy
- Lactation
- Cirrhosis
- History of chronic visible (gross) hemoptysis
- Hereditary hemochromatosis
Show all 10Show fewer
- History of transfusion-related iron overload
- Use of iron chelator(s)
- Withdrawal of informed consent
- Contraindication to phlebotomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Maine Medical Center
Portland, Maine, 04102
About this study
Official title: Iron Supplementation for the Hypoferremic Anemia of 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.
- Conditions
- Cystic Fibrosis, Anemia, Iron-Deficiency
- Being tested
- Ferrous sulfate 325mg, Placebo
- Keywords
- Cystic fibrosis, Iron, Hepcidin, Anemia, Erythropoiesis
- Medical subject headings
- Cystic Fibrosis, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate 325mgDrug
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
PlaceboDrug
Matching placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulfate 325mg | Active comparator | Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks Receives: Drug: Ferrous sulfate 325mg |
| Placebo | Placebo comparator | Identical-appearing tablet taken by mouth daily for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin Concentration (gm/dl)
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Change From Baseline in Serum Iron (mcg/dl)
Measured: Baseline and 6 weeks
Change From Baseline in Transferrin Saturation (%)
Measured: Baseline and 6 weeks
Change From Baseline in Sputum Iron (ng/mg)
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex H. Gifford, Dartmouth-Hitchcock Medical Center
- Investigators
- Alex H Gifford, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755455
- Sponsor's protocol ID
- D11176
- Other IDs
- CPHS#22884
- Status last verified
- Feb 2017
- First submitted
- 19 Dec 2012
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24332997
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01755455
- Acronym / sponsor ID
- D11176
- Conditions
- Cystic Fibrosis, Anemia, Iron-Deficiency
- Keywords
- Cystic fibrosis, Iron, Hepcidin, Anemia, Erythropoiesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate 325mg | Active comparator | Drug: Ferrous sulfate 325mgFerrous sulfate 325mg tablet taken by mouth daily for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIdentical-appearing tablet taken by mouth daily for 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- Use of iron-containing vitamin or supplement
- Pregnancy
- Lactation
- Cirrhosis
- History of chronic visible (gross) hemoptysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfate 325mgFerrous sulfate 325mg tablet taken by mouth daily for 6 weeks | Drug | Ferrous sulfate 325mg |
| PlaceboMatching placebo capsule | Drug | Placebo |
Primary outcome
Change From Baseline in Hemoglobin Concentration (gm/dl)
Time frame: Baseline and 6 weeks
3 secondary outcomes
Change From Baseline in Serum Iron (mcg/dl)
Time frame: Baseline and 6 weeks
Change From Baseline in Transferrin Saturation (%)
Time frame: Baseline and 6 weeks
Change From Baseline in Sputum Iron (ng/mg)
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24332997Gifford 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.
- Pubmed EntryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex H Gifford, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate 325mg in people with Cystic Fibrosis and Anemia, Iron-Deficiency, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin Concentration (gm/dl) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.