Omega-3 Supplementation and Depression Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi
ClinicalTrials.gov Identifier:
NCT01614249
First received: June 5, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:
  • Depressive symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Depressive symptoms will be measured using Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline, mid-point and end of study during the 8 week study period.


Secondary Outcome Measures:
  • omega-3 fatty acid status [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Omega-3 fatty acid levels will be analyzed from cheek cell samples collected at Baseline, mid-point and end of study during the 8 week study period.


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

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01614249

Locations
Kenya
Nairobi City Council Health Facilities
Nairobi, Kenya, 020
Sponsors and Collaborators
University of Nairobi
Investigators
Principal Investigator: Rose O. Opiyo, MSc University of Nairobi
  More Information

Publications:
Burr, G. and M. Burr, A new deficiency disease produced by the rigid exclusion of fat from the diet. . The Journal of Biological Chemistry 1929. 82: p. 345-367.

Responsible Party: Rose Okoyo Opiyo, Principal Investigator (PI), University of Nairobi
ClinicalTrials.gov Identifier: NCT01614249     History of Changes
Other Study ID Numbers: ODR-2011/2012, ECCT/12/03/01
Study First Received: June 5, 2012
Last Updated: April 24, 2014
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by University of Nairobi:
Omega-3
EPA
Depression
HIV infected
Pregnant women

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014