Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Michael O'Connor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00924547
First received: June 17, 2009
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cystic Fibrosis
Dietary Supplement: Docosahexanoic Acid Supplement
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Exhaled breath 8-isoprostane-PGFα and urine 8-isoprostane-PGFα [ Time Frame: 4 measurements: baseline and then one measurement after each of the three study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatty acid profile analysis including esterification sites in plasma [ Time Frame: 4 measurements - Baseline and then one measurement after each of the three study periods ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docosahexanoic Acid Supplement 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 Dietary Supplement: Placebo
Placebo identical to active treatment.

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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% or greater than 3 pulmonary exacerbations in the last year
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924547

Contacts
Contact: Michael G O'Connor, MD 615.343.7617 michael.g.oconnor@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael G O'Connor, MD    615-343-7617    michael.g.oconnor@vanderbilt.edu   
Contact: Michael Laposata, MD, PhD    615-322-4254    michael.laposata@vanderbilt.edu   
Principal Investigator: Michael G O'Connor, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael G O'Connor, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Michael O'Connor, Pediatric Pulmonary Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00924547     History of Changes
Other Study ID Numbers: 081363
Study First Received: June 17, 2009
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Cystic Fibrosis
Docosahexanoic Acid
DHA
isoprostanes
fatty acid

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

ClinicalTrials.gov processed this record on September 18, 2014