Status:
COMPLETED
Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
Lead Sponsor:
Vanderbilt University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
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 pr...
Detailed Description
The study design will be a single-center, randomized, placebo-controlled, cross-over trial. After informed consent has been obtained, 18 eligible subjects with pancreatic insufficient cystic fibrosis ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00924547
Start Date
November 1 2013
End Date
July 1 2015
Last Update
July 21 2015
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232