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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: Completed Phase 1 study of Heart Disease, sponsored by Cardiovascular Research Associates.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 120 participants
Start Date 2009-04
Est. Completion 2009-12
Phase Phase 1

What the finished NCT00988585 record still lists

NCT00988585 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 2,043-participant average among 31 other Heart Disease trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

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.

Where NCT00988585's enrollment target sits among peer trials

120 23rd of 31 higher than 8 of 31 other Heart Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00988585, the US trial registry maintained by the National Library of Medicine. NCT00988585 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.