CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 192 enrolled
Drug / intervention
Placebo +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01534533
NCT01534533Phase 3Completed
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The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Peking University·interventional·Posted Feb 16, 2012·Updated Jul 22, 2013

In Brief

A Phase 3 clinical trial evaluating Placebo, Lutein group, and 2 other interventions for Carotid Atherosclerosis and Carotid Intimal Medial Thickness 1. Completed, enrolled 192 participants across 1 site.

Detailed Summary

This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Atherosclerosis, Carotid Intimal Medial Thickness 1
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2012
Enrollment StartJun 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.4 years ago

Interventions

Placebodietary

one gelatine capsule containing starch per day, for 12 months

Lutein groupdietary

one gelatine capsule containing 20mg lutein per day, for 12 months

Combination groupdietary

one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months

Normal lutein control groupdietary

subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months