Effect of Fish Oil on Plasma Triglycerides in Adults
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults|
- Plasma Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- LDL particle size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Eligibility is first determined through a telephone screen or an on-line screening tool. Those potential subjects who meet the eligibility criteria over the telephone or on-line will be required to make two clinic visits to the GCRC and provide two blood samples within a 1-week window, which will be used to determine further eligibility. Those who are still eligible after the blood analyses will be invited to attend a group orientation session.
The rationale for the study and the entire protocol will be discussed at the group orientations, which will be held approximately twice/month. Informed consent will be obtained after all questions are answered.
Those who signed the informed consent will be randomized in blocks of 10 (3/assignment group: fish oil in triglyceride form, fish oil as ethyl ester, and placebo).
Baseline measurements will include:
Blood sampling (twice within a 1-week window) Questionnaires (specifically dietary assessment questionnaire)
The same assessments will be collected 12 weeks after randomization. An additional blood sample will be collected at 4 and 8 weeks. Four-week supplies of study tablets will be distributed at baseline and at weeks 4 and 8.
Blood sampling will be done at the General Clinical Research Center/CTRU by trained nurses.
All of the study procedures involve minimal or negligible risk.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804427
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Christopher D Gardner||Stanford University|