Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA) will result in normalization of the known fatty acid derangements in these patients and will diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.
Key facts
- Study ID
- NCT00924547
- Run by
- Vanderbilt University
- People needed
- 17
- Starts
- 2013-11-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-07-21
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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