Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis

NCT00924547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-07-21

No results posted yet for this study

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.

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

Placebo

Placebo identical to active treatment.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Michael G O'Connor, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00924547 on ClinicalTrials.gov