HypertriglyceridemiaOMEGANCT00504309

Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides

A study testing 4/day of 4g P-OM3 capsules and 4/day of 1g P-OM3 capsules in people with Hypertriglyceridemia, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Hypertriglyceridemia
What is being tested?: 4/day of 4g P-OM3 capsules and 4/day of 1g P-OM3 capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Jan 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

triglycerides 150-500 mg/dL
age 21-65 years
generally healthy
body mass index (BMI) 20-39 kg/m2

Who cannot join

smoking
premenopausal (if female)
use of hormone replacement or oral contraceptives
use of lipid lowering or blood pressure medication
hypertension (blood pressure > 150/95 mm Hg)
peripheral vascular disease

Show all 12Show fewer

heart disease, diabetes, or stroke
inflammatory disease (e.g. rheumatoid arthritis or Crohn's)
elevated liver enzymes
high intake of omega-3 containing foods
allergy to adhesive or latex
use of aspirin, anticoagulants, or SSRI

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State University General Clinical Research Center
University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Omacor: Measures of Endothelial Function and triGlyceride Alteration

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Conditions: Hypertriglyceridemia
Being tested: 4/day of 4g P-OM3 capsules, 4/day of 1g P-OM3 capsules, Corn Oil Placebo, 4 capsules/day for 8 weeks
Keywords: triglycerides, hypertriglyceridemia, omega-3, n-3, eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, flow mediated dilation, fish, Moderate hypertriglyceridemia
Medical subject headings: Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4/day of 4g P-OM3 capsulesDrug
Also called OM3AEE, Lovaza, Fish oil
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsulesDrug
Also called OM3AEE, Lovaza, Fish oil
4/day of 1g P-OM3 capsules for 8 weeks
Corn Oil Placebo, 4 capsules/day for 8 weeksDrug
Also called Corn oil
4 capsules per day of corn oil placebo for 8 weeks

Study groups in NCT00504309
Study group	Role	What they receive
4g P-OM3, then 1g P-OM3, then Placebo	Experimental	4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks). Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
1g P-OM3, then 4g P-OM3, then Placebo	Experimental	1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks. Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
Placebo, then 4g P-OM3, then 1g P-OM3	Experimental	Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks. Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4g P-OM3, then Placebo, then 1g P-OM3	Experimental	4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks. Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
1g P-OM3, then Placebo, then 4g P-OM3	Experimental	1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
Placebo, then 1g P-OM3, then 4g P-OM3	Experimental	Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. Receives: Drug: 4/day of 4g P-OM3 capsules; Drug: 4/day of 1g P-OM3 capsules; Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

Lipid Profile
Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.
Measured: 8 weeks
Flow-mediated Dilation (FMD)
Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.
Measured: 8 weeks
Blood Pressure
Effect of P-OM3 dose on blood pressure
Measured: 8 weeks
Heart Rate
Effect of P-OM3 dose on heart rate
Measured: 8 weeks

Secondary outcomes (7)

Erythrocyte Fatty Acids
Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Measured: 8 weeks
Cytokine Inflammatory Markers
Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Measured: 8 weeks
Fasting Glucose
Effect of P-OM3 dose on fasting glucose
Measured: 8 weeks
Psychosocial Profile Questionnaires
Effect of P-OM3 dose on psychosocial questionnaires:
Perceived Stress Scale (PSS)
- 14 questions, scored 0-4 based on how often the subject felt certain emotions
- Scores: 0 to 40; higher scores indicate higher perceived stress
Spielberger State Anxiety Inventory
- Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale
- Scores: 20 to 80; higher scores indicate higher levels of anxiety
Positive and Negative Affect Scales (PANAS)
- Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much).
- Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect
Center for Epidemiologic Studies Depression (CES-D) Scale
- 20 questions about symptoms of depression in the past week
- Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional
Measured: 8 weeks
C-reactive Protein (CRP)
Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Measured: 8 weeks
Fasting Insulin
Effect of P-OM3 dose on fasting insulin
Measured: 8 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).
HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405.
QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)).
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Jan 2009

First posted20 Jul 2007 (estimated)
Study startJul 2007
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
More trials run by Penn State UniversityThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00504309
Sponsor's protocol ID: G214
Acronym: OMEGA
Status last verified: Feb 2018
First submitted: 19 Jul 2007
Last updated: 13 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sauder KA, Skulas-Ray AC, Campbell TS, Johnson JA, Kris-Etherton PM, West SG. Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia. Psychosom Med. 2013 May;75(4):382-9. doi: 10.1097/PSY.0b013e318290a107. Epub 2013 Apr 16.
PubMed 23592752
Skulas-Ray AC, Kris-Etherton PM, Harris WS, West SG. Effects of marine-derived omega-3 fatty acids on systemic hemodynamics at rest and during stress: a dose-response study. Ann Behav Med. 2012 Dec;44(3):301-8. doi: 10.1007/s12160-012-9393-2.
PubMed 22865498
Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15.
PubMed 21159789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omacor: Measures of Endothelial Function and triGlyceride Alteration
ClinicalTrials.gov ID: NCT00504309
Acronym / sponsor ID: OMEGA / G214
Conditions: Hypertriglyceridemia
Keywords: triglycerides, hypertriglyceridemia, omega-3, n-3, eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: Reliant Pharmaceuticals
Study start: Jul 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 20 Jul 2007 (estimated)
Results: Posted 13 Mar 2018

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 evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
4g P-OM3, then 1g P-OM3, then Placebo	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
1g P-OM3, then 4g P-OM3, then Placebo	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
Placebo, then 4g P-OM3, then 1g P-OM3	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeksCorn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
4g P-OM3, then Placebo, then 1g P-OM3	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
1g P-OM3, then Placebo, then 4g P-OM3	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
Placebo, then 1g P-OM3, then 4g P-OM3	Experimental	Drug: 4/day of 4g P-OM3 capsules, Drug: 4/day of 1g P-OM3 capsules, Drug: Corn Oil Placebo, 4 capsules/day for 8 weeksCorn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

triglycerides 150-500 mg/dL
age 21-65 years
generally healthy
body mass index (BMI) 20-39 kg/m2

Key exclusion criteria (12 listed)

smoking
premenopausal (if female)
use of hormone replacement or oral contraceptives
use of lipid lowering or blood pressure medication
hypertension (blood pressure > 150/95 mm Hg)

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
4/day of 4g P-OM3 capsulesAlso: OM3AEE, Lovaza, Fish oil4/day of 4g P-OM3 capsules for 8 weeks	Drug	1g P-OM3, then 4g P-OM3, then Placebo, 1g P-OM3, then Placebo, then 4g P-OM3, 4g P-OM3, then 1g P-OM3, then Placebo, 4g P-OM3, then Placebo, then 1g P-OM3, Placebo, then 1g P-OM3, then 4g P-OM3, Placebo, then 4g P-OM3, then 1g P-OM3
4/day of 1g P-OM3 capsulesAlso: OM3AEE, Lovaza, Fish oil4/day of 1g P-OM3 capsules for 8 weeks	Drug	1g P-OM3, then 4g P-OM3, then Placebo, 1g P-OM3, then Placebo, then 4g P-OM3, 4g P-OM3, then 1g P-OM3, then Placebo, 4g P-OM3, then Placebo, then 1g P-OM3, Placebo, then 1g P-OM3, then 4g P-OM3, Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil Placebo, 4 capsules/day for 8 weeksAlso: Corn oil4 capsules per day of corn oil placebo for 8 weeks	Drug	1g P-OM3, then 4g P-OM3, then Placebo, 1g P-OM3, then Placebo, then 4g P-OM3, 4g P-OM3, then 1g P-OM3, then Placebo, 4g P-OM3, then Placebo, then 1g P-OM3, Placebo, then 1g P-OM3, then 4g P-OM3, Placebo, then 4g P-OM3, then 1g P-OM3

Primary outcome

Lipid Profile
Time frame: 8 weeks
Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.
Flow-mediated Dilation (FMD)
Time frame: 8 weeks
Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.
Blood Pressure
Time frame: 8 weeks
Effect of P-OM3 dose on blood pressure
Heart Rate
Time frame: 8 weeks
Effect of P-OM3 dose on heart rate

7 secondary outcomes

Erythrocyte Fatty Acids
Time frame: 8 weeks
Cytokine Inflammatory Markers
Time frame: 8 weeks
Fasting Glucose
Time frame: 8 weeks
Psychosocial Profile Questionnaires
Time frame: 8 weeks
C-reactive Protein (CRP)
Time frame: 8 weeks
Fasting Insulin
Time frame: 8 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 13 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4g P-OM3, Then 1g P-OM3, Then Placebo	7	7
1g P-OM3, Then 4g P-OM3, Then Placebo	5	5
Placebo, Then 4g P-OM3, Then 1g P-OM3	2	1
4g P-OM3, Then Placebo, Then 1g P-OM3	3	3
1g P-OM3, Then Placebo, Then 4g P-OM3	8	7
Placebo, Then 1g P-OM3, Then 4g P-OM3	3	3

Primary outcome: Lipid Profile

Time frame: 8 weeks. Mean (Standard Error). Unit: mg/dL

Measure	4g P-OM3 n = 26	1g P-OM3 n = 26	Placebo n = 26
High density lipoprotein-cholesterol (HDL-C)	43.2 (1.9)	42.7 (1.9)	42.6 (1.9)
Low density lipoprotein-cholesterol (LDL-C)	130.3 (7.6)	127.6 (7.6)	123.3 (7.6)
Total Cholesterol	207.9 (7.9)	212.1 (7.9)	209 (7.9)
Triglycerides	173.7 (17.5)	215.3 (17.5)	237.3 (17.5)

4g P-OM3 vs 1g P-OM3 vs Placebo: p = 0.002, Mixed Models Analysis
4g P-OM3 vs 1g P-OM3 vs Placebo: p > 0.05, Mixed Models Analysis

Primary outcome: Flow-mediated Dilation (FMD)

Time frame: 8 weeks. Mean (Standard Error). Unit: % change in brachial artery diameter

Measure	4g P-OM3 n = 26	1g P-OM3 n = 26	Placebo n = 26
Value	5.00 (0.5)	4.03 (0.5)	5.00 (0.5)

Primary outcome: Blood Pressure

Time frame: 8 weeks. Mean (Standard Error). Unit: mm Hg

Measure	4g P-OM3 n = 26	1g P-OM3 n = 26	Placebo n = 26
Diastolic blood pressure (DBP)	76.1 (1.6)	77.7 (1.6)	77.8 (1.6)
Systolic blood pressure (SBP)	126.3 (2.2)	129.0 (2.2)	128.4 (2.2)

Population analysed: Two participants did not complete the study and were therefore excluded from analysis.

Primary outcome: Heart Rate

Time frame: 8 weeks. Mean (Standard Error). Unit: beats per minute

Measure	4g P-OM3 n = 26	1g P-OM3 n = 26	Placebo n = 26
Value	67.9 (1.8)	69.8 (1.8)	71.8 (1.8)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected while participants were enrolled (approximately 2.5 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4g P-OM3	0 of 27 (0%)	1 of 27 (3.7%)	Not reported
1g P-OM3	0 of 27 (0%)	0 of 27 (0%)	Not reported
Placebo	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23592752Sauder KA, Skulas-Ray AC, Campbell TS, Johnson JA, Kris-Etherton PM, West SG. Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia. Psychosom Med. 2013 May;75(4):382-9. doi: 10.1097/PSY.0b013e318290a107. Epub 2013 Apr 16.
Derived from this study: PubMed 22865498Skulas-Ray AC, Kris-Etherton PM, Harris WS, West SG. Effects of marine-derived omega-3 fatty acids on systemic hemodynamics at rest and during stress: a dose-response study. Ann Behav Med. 2012 Dec;44(3):301-8. doi: 10.1007/s12160-012-9393-2.
Derived from this study: PubMed 21159789Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15.

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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.

Sheila G West, PhD principal investigator

Penn State University

Penny M Kris-Etherton, PhD principal investigator

Penn State University

Ann C Skulas-Ray, B.S. principal investigator

Penn State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 4/day of 4g P-OM3 capsules and 4/day of 1g P-OM3 capsules in people with Hypertriglyceridemia, run by Penn State 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 4 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 13 Mar 2018. 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. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Lipid Profile (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 NCT00504309, which also lists 3 linked publications.

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 13 Mar 2018.