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| ID | Type | Description | Link |
|---|---|---|---|
| CPHS#22884 | Other Grant/Funding Number | The Flatley Foundation |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous sulfate 325mg | Active Comparator | Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks |
|
| Placebo | Placebo Comparator | Identical-appearing tablet taken by mouth daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate 325mg | Drug | Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin Concentration (gm/dl) | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex H Gifford, M.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States | ||
| Dartmouth-Hitchcock Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24332997 | Result | 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. |
| Label | URL |
|---|---|
| Pubmed Entry | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
| |||||||||||||
| Washout (4 Weeks) |
| |||||||||||||
| Second Intervention (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes those who started the study with First Intervention and those who started the study with Second Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin Concentration (gm/dl) | Posted | Mean | Standard Error | gm/dl | Baseline and 6 weeks |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Events observed among all participants while they were receiving placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex H. Gifford, M.D. | Dartmouth-Hitchcock Medical Center | 603-650-5533 | alex.h.gifford@hitchcock.org |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| Placebo | Drug | Matching placebo capsule |
|
| Baseline and 6 weeks |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Serum Iron (mcg/dl) | Posted | Mean | Standard Error | mcg/dl | Baseline and 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in Transferrin Saturation (%) | Posted | Mean | Standard Error | % saturation | Baseline and 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in Sputum Iron (ng/mg) | Posted | Mean | Standard Error | ng/mg | Baseline and 6 weeks |
|
|
|
|
| 4 |
| 22 |
| 13 |
| 22 |
| EG001 | Ferrous Sulfate | Events observed among all participants while they were receiving ferrous sulfate. | 3 | 22 | 11 | 22 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |