Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
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|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|
|Actual Primary Completion Date :||May 2015|
|Actual 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 ]
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 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|