774
Participants
Start Date
April 17, 2018
Primary Completion Date
March 31, 2020
Study Completion Date
March 31, 2020
Omega-3 treatment
"Patient in the treatment comparative arm will consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day)."
Placebo
"The appearance and taste of the placebo will be similar to those of the active ingredient. Placebo capsules contained a 1:1 ratio of corn oil and soy oil.~36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment. Active treatment consists of 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day).~For the 18 months placebo-controlled period (n=200/arm): 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day) or placebo (3 similar pills /day)."
University Hospital Toulouse, Toulouse
University Hospital, Toulouse
OTHER