Omega-3 Supplementation and Depression Clinical Trial
This study is enrolling participants by invitation only.
Sponsor:
University of Nairobi
Information provided by (Responsible Party):
Rose Okoyo Opiyo, University of Nairobi
ClinicalTrials.gov Identifier:
NCT01614249
First received: June 5, 2012
Last updated: June 25, 2012
Last verified: June 2012
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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 anti-retroviral 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 gel placebo Dietary Supplement: Fish oil omega-3 EPA rich supplement |
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.
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Soybean oil soft gels
Participants on this arm will receive 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 gel placebo
Each participant will receive 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 placebo
|
|
Experimental: Fish oil omega-3
Participants on this arm will receive fish oil omega-3 EPA-rich supplements for 8 weeks with bi-weekly follow-up visits for monitoring of side effects and compliance.
|
Dietary Supplement: Fish oil omega-3 EPA rich supplement
A total of 3.0g omega-3 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
|
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 More Information
No publications provided
| 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: | June 25, 2012 |
| 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 Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on March 07, 2013
