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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT00924547 |
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Date of registration:
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17/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
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Scientific title:
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Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00924547 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael G O'Connor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Cystic Fibrosis based on sweat chloride value > 60 mEq/L or genotyping
- Pancreatic insufficiency, defined by requirement for treatment with exogenous
pancreatic enzymes
- FEV 1 > 40
- Less than 3 pulmonary exacerbations in the last year (as diagnosed by pulmonary
attending physician)
- Age greater than 6 years
- Capability of performing pulmonary function tests
- Ability to swallow gel capsule
- Ability to comply with medication use, study visits, and study procedures
- Written informed consent obtained from subject or study subject's legal
representative
Exclusion Criteria:
- Presence of severe CF-related liver disease, including SGOT or SGPT>3 times the
normal limits, history of biliary cirrhosis, or portal hypertension
- Severe pulmonary disease, as defined by FEV1 < 40%
- Elevated serum creatinine or BUN
- Pregnancy
- PT >1.5 time normal
- Diabetes mellitus
- Daily use of NSAIDs or other anticoagulants
- History of fish allergy
- Use of ticlopidine, clopidogrel, dipyridamole
- Use of glucocorticoids
- History of lung transplant or currently on lung transplantation list
- Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the subject or the quality of the data
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Docosahexanoic Acid Supplement
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Primary Outcome(s)
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Exhaled breath 8-isoprostane-PGFa and urine 8-isoprostane-PGFa
[Time Frame: 4 measurements: baseline and then one measurement after each of the three 4-week study periods]
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Secondary Outcome(s)
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Fatty acid profile analysis including esterification sites in plasma
[Time Frame: 4 measurements - Baseline and then one measurement after each of the three 4-week study periods]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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