Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00988585 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
A Phase 1 study of Heart Disease, sponsored by Cardiovascular Research Associates.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT00988585 is a Phase 1 study of Heart Disease that has completed, run by Cardiovascular Research Associates. The registered enrollment target is 120 participants, below the 2,043-participant average among 31 other Heart Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00988585, a Phase 1 study of Heart Disease, has completed, sponsored by Cardiovascular Research Associates.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT DHA
- DIETARY_SUPPLEMENT Olive Oil
- DIETARY_SUPPLEMENT EPA 600
- DIETARY_SUPPLEMENT EPA 1800
Study Locations (1)
Massachusetts
- Cardiovascular Research Associates - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988585
The ClinicalTrials.gov registry entry for NCT00988585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,043-participant average among 31 other Heart Disease trials with a reported enrollment target (94% lower). The listed sponsor is Cardiovascular Research Associates, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Disease appearing as the primary indexed condition, and to 4 interventions - of which DHA is the first listed.
NCT00988585 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00988585 about?
NCT00988585 is a clinical study titled "Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil". The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA...
What is the current status of trial NCT00988585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2009-04. Estimated completion is 2009-12.
What conditions does trial NCT00988585 study?
This clinical trial studies the following conditions: Heart Disease.
What interventions are being tested in trial NCT00988585?
The interventions under investigation include: DHA (DIETARY_SUPPLEMENT), Olive Oil (DIETARY_SUPPLEMENT), EPA 600 (DIETARY_SUPPLEMENT), EPA 1800 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00988585?
This trial is sponsored by Cardiovascular Research Associates, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00988585 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Disease
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.
-
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
COMPLETED · Phase 1
-
Sildenafil in Single Ventricle Patients
COMPLETED · Phase 1
-
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
COMPLETED · Phase 1
-
Studies of Neuregulin/ERBB Signaling in Human Heart
RECRUITING
-
Promoting Physical Activity and Fitness Among Underserved Latino Families Living in U.S.-Mexico Border Regions
RECRUITING · NA
-
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.