Omega-3 Supplementation and Depression Clinical Trial

NCT01614249 | Completed Results DMC

• 2 other identifiers: ODR-2011/2012ECCT/12/03/01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Symptoms

Keywords

Omega-3; EPA; Depression; HIV infected; Pregnant women

Outcome Measures

Primary Outcomes (1)

• Change in BDI-II Depressive Symptom Scores

  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.

  8 weeks

Study Arms (2)

Soybean oil soft gels

PLACEBO COMPARATOR

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

Fish oil omega-3 EPA-rich soft gels

EXPERIMENTAL

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

Interventions

Soybean oil soft gels DIETARY_SUPPLEMENT

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

Also known as: OmegaVia Soybean oil soft gels

Soybean oil soft gels

Fish oil omega-3 EPA-rich soft gels DIETARY_SUPPLEMENT

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.

Also known as: OmegaVia fish oil omega-3 EPA-rich soft gels

Fish oil omega-3 EPA-rich soft gels

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nairobi: lead
• Consortium for Advanced Research Training in Africa (CARTA): collaborator
• Innovix Pharma Inc.: collaborator

Study Sites (1)

Nairobi City Council Health Facilities

Nairobi, 020, Kenya

Location

Related Publications (34)

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  PMID: 30534187 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Omega-3 intake value based on international database due to absence in local food composition database. Cellular level EPA/DHA not reported due to technical problems with collected samples.

Results Point of Contact

• Title: Mrs. Rose Okoyo Opiyo
• Organization: University of Nairobi

roseopiyo@uonbi.ac.ke

+254 020 2726300

Study Officials

• Rose O. Opiyo, MSc

  University of Nairobi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 28, 2018
• Results First Posted: March 8, 2016

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)