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NCT02014181 · ClinicalTrials.gov registry record · Phase 1
Flaxseed Modulates Inflammation and Oxidative Stress in CF
A Phase 1 study of Cystic Fibrosis and Inflammation, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02014181: Completed Phase 1 study of Cystic Fibrosis and Inflammation, sponsored by University of Pennsylvania.
NCT02014181 is a Phase 1 study of Cystic Fibrosis and Inflammation that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02014181, a Phase 1 study of Cystic Fibrosis and Inflammation, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a mutation in sodium and chloride transport channels that results in pancreatic insufficiency, chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic inflammation and oxidative stress are a part of the chronic exacerbations that are a part of cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and antioxidative properties can help dampen these stressors on the CF lung and potentially result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved well-being.
Primary Outcome
10 patients with cystic fibrosis were asked to consume 40 grams daily of finely ground flaxseed powder (however they wished) for one month. To assess side effects, each patient kept a journal to ascertain what side effects (if any) were most common among consumers of this dose of flaxseed. Side effects could include, but were not limited to, nausea, bloating, diarrhea or constipation. Other even rarer side effects could be bleeding, flushing, or anaphylaxis.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT finely ground flaxseed powder
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT02014181 record still lists
NCT02014181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which finely ground flaxseed powder is the first listed.
NCT02014181 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02014181 about?
NCT02014181 is a clinical study titled "Flaxseed Modulates Inflammation and Oxidative Stress in CF". Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a mutation in sodium and chlorid...
What is the current status of trial NCT02014181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-07. Estimated completion is 2013-01.
What conditions does trial NCT02014181 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Inflammation, Oxidative Stress.
What interventions are being tested in trial NCT02014181?
The interventions under investigation include: finely ground flaxseed powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02014181?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02014181 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02014181's enrollment target sits among peer trials
10 159th of 169 higher than 9 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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