Omega-3 Supplementation and Depression Clinical Trial
|ClinicalTrials.gov Identifier: NCT01614249|
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms||Dietary Supplement: Soybean oil soft gels Dietary Supplement: Fish oil omega-3 EPA-rich soft gels||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Role of Omega-3 Fish Oil Fatty Acids on Depression Among HIV-seropositive Pregnant Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||January 2014|
Placebo Comparator: Soybean oil soft gels
Participants on this arm will receive a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.
Dietary Supplement: Soybean oil soft gels
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
Other Name: OmegaVia Soybean oil soft gels
Experimental: Fish oil omega-3 EPA-rich soft gels
Participants will receive OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.
Dietary Supplement: Fish oil omega-3 EPA-rich soft gels
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.
Other Name: OmegaVia fish oil omega-3 EPA-rich soft gels
- Change in BDI-II Depressive Symptom Scores [ Time Frame: 8 weeks ]Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614249
|Nairobi City Council Health Facilities|
|Nairobi, Kenya, 020|
|Principal Investigator:||Rose O. Opiyo, MSc||University of Nairobi|