CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
Soybean oil soft gels +1 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/NCT01614249
NCT01614249N/ACompleted

Role of Omega-3 Fish Oil Fatty Acids on Depression Among HIV-seropositive Pregnant Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial

University of Nairobi·interventional·Posted Jun 7, 2012·Updated Jun 28, 2018

In Brief

A clinical study evaluating Soybean oil soft gels and Fish oil omega-3 EPA-rich soft gels for Depressive Symptoms. Completed, enrolled 216 participants across 1 site.

Detailed Summary

Fish oil omega-3 supplements provide essential nutrients for brain health and functioning. These nutrients have been proven to be effective in reducing depressive symptoms. They have also been found to be effective and well tolerated in reducing the bad fat accumulation among patients infected with human immunodeficiency virus (HIV)and are using highly active antiretroviral treatment. The role of this nutritional supplement in combating depression among pregnant women who are living with HIV infection has however not been established. Yet, currently, more than 2 million pregnant women are estimated to be living with HIV infection globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive. In this study, it is hypothesized that there is no difference in the levels of depressive symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and those taking a placebo. The study will therefore seek to ascertain that taking omega-3 fish oil nutritional supplement has a significant positive effect on depressive symptoms among HIV infected pregnant women, compared to a placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2012
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.1 years ago

Interventions

Soybean oil soft gelsdietary

Each participant will receive OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks

Fish oil omega-3 EPA-rich soft gelsdietary

A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels will be taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.