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Omega-3 Supplementation and Depression Clinical Trial

This study has been completed.
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi Identifier:
First received: June 5, 2012
Last updated: February 9, 2016
Last verified: February 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 Intervention Phase
Depressive Symptoms
Dietary Supplement: Soybean oil soft gels
Dietary Supplement: Fish oil omega-3 EPA-rich soft gels
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by University of Nairobi:

Primary Outcome Measures:
  • 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.

Enrollment: 216
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All pregnant HIV seropositive women with known CD4 cell count less than 500
  • Pregnant women who are in their 2nd trimester of pregnancy (Week 13-27).
  • Normal nutritional status pregnancy with mid-upper arm circumference (MUAC of 22 cm - 33 cm)at entry into the study;
  • Beck Depression Inventory Second Edition (BDI-II) Scale scores at entry into the study of 14 or more;
  • Pregnant HIV positive women who will give consent to participate in the study

Exclusion Criteria:

  • Underweight with MUAC less than 22 cm and overweight with MUAC more than 33 cm at entry into the study;
  • Pregnant women taking antidepressant medications;
  • Those on anti-clotting medication (those with liver disease, varicose veins, peptic ulcers); or Vitamin K supplement. Omega-3 supplements may increase their effects;
  • Those on diabetic medication since Omega-3 may increase their blood sugar.
  • Incomplete depression screening form (more than 5 items unanswered)
  • Those whose BDI-II screening scores are less than 14;
  • Those women currently taking omega-3 nutritional supplement
  • Pregnant HIV-seropositive women without consent to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01614249

Nairobi City Council Health Facilities
Nairobi, Kenya, 020
Sponsors and Collaborators
University of Nairobi
Consortium for Advanced Research Training in Africa (CARTA)
Innovix Pharma Inc.
Principal Investigator: Rose O. Opiyo, MSc University of Nairobi
  More Information

Jones, P. and A. Papamandjaris, eds. Lipid: Cellular Metabolism in Present Knowledge in Nutrition. 8th ed. Present Knowledge in Nutrition, ed. B. Bowman and R. Russell2001, ILSI Press: Washington, DC. 104-114.
Stoll, A., The Omega-3 connection.2001, New York.: Simon & Schuster.
WHO/UNAIDS/UNICEF, Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector. Progress Report, April 2007., 2007.
Melina, V. and B. Davis, The New Becoming Vegetarian. The essential guide to a healthy vegetarian diet. 2003, Tennessee: Healthy Living Publications.
NASCOP, Kenya AIDS Indicator Survey, (KAIS) 2007, 2009, NASCOP: Nairobi. p. 11.
KNBS, Kenya 2009 Population and Housing Census, M.o.P.a.N. Development, Editor 2010, Government Printers: Nairobi.
NASCOP/MOH/CDC, Sentinel Surveillance of HIV & STDs in Kenya Report 2006, 2006, NASCOP: Nairobi.

Responsible Party: Rose Okoyo Opiyo, Principal Investigator (PI), University of Nairobi Identifier: NCT01614249     History of Changes
Other Study ID Numbers: ODR-2011/2012
ECCT/12/03/01 ( Registry Identifier: Pharmacy and Poisons Board, Kenya )
Study First Received: June 5, 2012
Results First Received: November 25, 2015
Last Updated: February 9, 2016

Keywords provided by University of Nairobi:
HIV infected
Pregnant women

Additional relevant MeSH terms:
Behavioral Symptoms processed this record on May 25, 2017