Cystic FibrosisPhase 2NCT00924547
Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis
A Phase 2 study testing Docosahexanoic Acid Supplement in people with Cystic Fibrosis, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Docosahexanoic Acid Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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%
- Elevated serum creatinine or BUN
- Pregnancy
- PT >1.5 time normal
- Diabetes mellitus
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Docosahexanoic Acid Supplement, Placebo
- Keywords
- Cystic Fibrosis, Docosahexanoic Acid, DHA, isoprostanes, fatty acid
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexanoic Acid SupplementDietary supplement
Also called Martek, DHA
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.
PlaceboDietary supplement
Placebo identical to active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Docosahexanoic Acid Supplement | Experimental | In this arm, participants took two different doses of a DHA supplement. Each dose of the DHA supplement was taken for 4 weeks. Receives: Dietary Supplement: Docosahexanoic Acid Supplement |
| Placebo | Placebo comparator | In this arm, participants took a placebo pill that did not contain any DHA. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath 8-isoprostane-PGFα and urine 8-isoprostane-PGFα
Measured: 4 measurements: baseline and then one measurement after each of the three 4-week study periods
Secondary outcomes (1)
Fatty acid profile analysis including esterification sites in plasma
Measured: 4 measurements - Baseline and then one measurement after each of the three 4-week study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael O'Connor, Vanderbilt University
- Investigators
- Michael G O'Connor, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924547
- Sponsor's protocol ID
- 081363
- Status last verified
- Jul 2015
- First submitted
- 17 Jun 2009
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma
- ClinicalTrials.gov ID
- NCT00924547
- Acronym / sponsor ID
- 081363
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Docosahexanoic Acid, DHA, isoprostanes, fatty acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexanoic Acid Supplement | Experimental | Dietary Supplement: Docosahexanoic Acid SupplementIn this arm, participants took two different doses of a DHA supplement. Each dose of the DHA supplement was taken for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIn this arm, participants took a placebo pill that did not contain any DHA. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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%
- Elevated serum creatinine or BUN
- Pregnancy
- PT >1.5 time normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexanoic Acid SupplementAlso: Martek, DHAThe 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 | Docosahexanoic Acid Supplement |
| PlaceboPlacebo identical to active treatment. | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G O'Connor, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docosahexanoic Acid Supplement in people with Cystic Fibrosis, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.