|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01755455 |
|
Date of registration:
|
19/12/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
|
|
Scientific title:
|
Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis |
|
Date of first enrolment:
|
June 2011 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01755455 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Alex H Gifford, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Dartmouth-Hitchcock Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Anemia, Iron-Deficiency
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Ferrous sulfate 325mg
|
|
Primary Outcome(s)
|
|
Change From Baseline in Hemoglobin Concentration (gm/dl)
[Time Frame: Baseline and 6 weeks]
|
|
Secondary Outcome(s)
|
|
Change From Baseline in Transferrin Saturation (%)
[Time Frame: Baseline and 6 weeks]
|
|
Change From Baseline in Serum Iron (mcg/dl)
[Time Frame: Baseline and 6 weeks]
|
|
Change From Baseline in Sputum Iron (ng/mg)
[Time Frame: Baseline and 6 weeks]
|
|
Secondary ID(s)
|
|
CPHS#22884
|
|
D11176
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|