Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924547
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : July 21, 2015
Information provided by (Responsible Party):
Michael O'Connor, Vanderbilt University

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 production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Docosahexanoic Acid Supplement Dietary Supplement: Placebo Phase 2

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 will be enrolled in the study. Participants will take part in two 4 week study sessions, each separated by a 4 week washout period. One session will involve treatment with placebo and the other two sessions will provide treatment with approximately 25mg and 35 mg of DHA/kg of body weight. The patients will be assigned to each of the treatment sessions in random order, as described above. The DHA source will be provided by Martek Biosciences Corporation, Columbia, MD, USA in the form of a chewable capsule containing 200 mg of DHA. The placebos will be identical to the DHA supplement but will not contain the active ingredient, DHA. Subjects will be instructed to take the study capsules in addition to their normal doses of pancreatic enzymes with meals and to maintain their usual diets. Blood, urine, and exhaled breath condensate samples will be collected at baseline and after completion of each of the study periods. Patients will be screened and enrolled when they present to clinic for their routine check-up. The subjects have routine blood work at their annual check-ups, and when possible will have an additional tube of blood saved for the baseline fatty acid profiles so as to avoid unnecessary blood draws. Following each study period, blood draw, urine collection, and exhaled breath condensate (EBC) will be collected at the Vanderbilt Clinical Research Center. The patients will also be given the supply of DHA and placebo (for the entire study) at time of enrollment. The order in which they take the supplement or the placebo will be determined using a randomization table.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma
Study Start Date : November 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Docosahexanoic Acid Supplement
In this arm, participants took two different doses of a DHA supplement. Each dose of the DHA supplement was taken for 4 weeks.
Dietary Supplement: Docosahexanoic Acid Supplement

The active treatment will consist of Martek's chewable DHA capsules containing 200mg in each capsule. The treatment will be provided as approximately 25mg/kg/day and 35mg/kg/day.

These dosages will be divided BID-TID and will be given for 4 weeks.

Other Names:
  • Martek
  • DHA
Placebo Comparator: Placebo
In this arm, participants took a placebo pill that did not contain any DHA.
Dietary Supplement: Placebo
Placebo identical to active treatment.

Primary Outcome Measures :
  1. Exhaled breath 8-isoprostane-PGFα and urine 8-isoprostane-PGFα [ Time Frame: 4 measurements: baseline and then one measurement after each of the three 4-week study periods ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924547

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Michael G O'Connor, MD Vanderbilt University

Responsible Party: Michael O'Connor, Pediatric Pulmonary Fellow, Vanderbilt University Identifier: NCT00924547     History of Changes
Other Study ID Numbers: 081363
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Michael O'Connor, Vanderbilt University:
Cystic Fibrosis
Docosahexanoic Acid
fatty acid

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases