Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT00924547|
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Dietary Supplement: Docosahexanoic Acid Supplement Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||May 2015|
|Study Completion Date :||July 2015|
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.
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924547
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Michael G O'Connor, MD||Vanderbilt University|