N/A
N=216
Omega-3 Supplementation and Depression Clinical Trial
Depressive Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01614249 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change in BDI-II Depressive Symptom Scores — -13.9; -13.3 scores on BDI-II scale — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soybean oil soft gels (Dietary_supplement); Fish oil omega-3 EPA-rich soft gels (Dietary_supplement)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Nairobi
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BDI-II Depressive Symptom Scores |
-13.9; -13.3 | 0.21 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01614249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.