HypertriglyceridemiaDHA-ONCT01737099
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
A study testing DHA-O and Fish oil in people with Hypertriglyceridemia, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- DHA-O and Fish oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-79
- fasting TG levels, 150-499 mg/dL
- baseline DHA intake <200mg/d
- active and in good health
Who cannot join
- recent diagnosis of CHD or history of revascularization within 6mos of study
- use of lipid altering medications (other than stable statins)
- use of anticoagulants
- use of omega-3 products within 4 weeks of screening
- serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening
- lipid altering foods or supplements
Show all 9Show fewer
- women who are pregnant or of childbearing potential not using adequate birth control
- current use or history of drug or alcohol abuse
- inability to swallow capsules
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.
- Conditions
- Hypertriglyceridemia
- Being tested
- DHA-O, Fish oil, Placebo
- Keywords
- omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-ODietary supplement
Fish oilDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DHA-O | Experimental | Not described Receives: Dietary Supplement: DHA-O |
| Fish oil | Active comparator | Not described Receives: Dietary Supplement: Fish oil |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TG levels
Measured: week 14
Secondary outcomes (1)
Change from baseline in lipid panel measures
Measured: week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Principal investigator, Biofortis Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737099
- Sponsor's protocol ID
- 2012-1048
- Acronym
- DHA-O
- Status last verified
- Apr 2014
- First submitted
- 27 Nov 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Maki KC, Yurko-Mauro K, Dicklin MR, Schild AL, Geohas JG. A new, microalgal DHA- and EPA-containing oil lowers triacylglycerols in adults with mild-to-moderate hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):141-8. doi: 10.1016/j.plefa.2014.07.012. Epub 2014 Jul 22.
PubMed 25123060
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01737099
- Acronym / sponsor ID
- DHA-O / 2012-1048
- Conditions
- Hypertriglyceridemia
- Keywords
- omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Nov 2012 (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.
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DHA-O | Experimental | Dietary Supplement: DHA-O |
| Fish oil | Active comparator | Dietary Supplement: Fish oil |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages 18-79
- fasting TG levels, 150-499 mg/dL
- baseline DHA intake <200mg/d
- active and in good health
Key exclusion criteria (9 listed)
- recent diagnosis of CHD or history of revascularization within 6mos of study
- use of lipid altering medications (other than stable statins)
- use of anticoagulants
- use of omega-3 products within 4 weeks of screening
- serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening
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 |
|---|---|---|
| DHA-O | Dietary supplement | DHA-O |
| Fish oil | Dietary supplement | Fish oil |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in TG levels
Time frame: week 14
1 secondary outcome
Change from baseline in lipid panel measures
Time frame: week 14
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 25 Apr 2014.
- Derived from this study: PubMed 25123060Maki KC, Yurko-Mauro K, Dicklin MR, Schild AL, Geohas JG. A new, microalgal DHA- and EPA-containing oil lowers triacylglycerols in adults with mild-to-moderate hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):141-8. doi: 10.1016/j.plefa.2014.07.012. Epub 2014 Jul 22.
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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.
Kevin Maki, PhD principal investigator
Biofortis Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA-O and Fish oil in people with Hypertriglyceridemia, run by dsm-firmenich Switzerland AG 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 4 inclusion and 9 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 25 Apr 2014. 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.
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?
Change from baseline in TG levels (time frame: week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737099, which also lists 1 linked publication.
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 25 Apr 2014.