Effect of fish oil omega-3 fatty acids on reduction of depressive symptoms among HIV-seropositive pregnant women: a randomized, double-blind controlled trial

Rose Okoyo Opiyo, Peter Suwirakwenda Nyasulu, Reuben Kamau Koigi, Anne Obondo, Dorington Ogoyi, Wambui Kogi-Makau, Rose Okoyo Opiyo, Peter Suwirakwenda Nyasulu, Reuben Kamau Koigi, Anne Obondo, Dorington Ogoyi, Wambui Kogi-Makau

Abstract

Background: Globally, it is known that HIV-infected pregnant women are prone to depressive symptoms. Research evidences also suggest that nutrient deficiencies may enhance the depressive illness, and that fish oil omega-3 fatty acids may alleviate the depressive symptoms. The aim of this study was to assess the effect of fish oil omega-3 eicosapentaenoic acid-rich supplements on depressive symptoms among HIV-seropositive pregnant women.

Trial design: A randomized double-blinded controlled trial with two parallel groups was conducted. The intervention group received fish oil omega-3 of 3.17 g (eicosapentaenoic acid = 2.15 g; docosahexaenoic acid = 1.02 g) per day for 8 weeks, while the control group received soybean oil for a similar period.

Method: Participants were HIV-seropositive pregnant women who were enrolled in prevention of mother-to-child transmission programs and attending antenatal clinics at selected Nairobi city county's health facilities. Recruitment was done from health records of HIV-infected pregnant women. Data analysis followed per-protocol analysis. Participants who completed the 8-week trial were included in the analysis of covariance statistical model with omega-3 as main effect. The covariates in the change in BDI-II depressive symptom score outcome were baseline characteristics and nutrient adequacy.

Results: 282 participants were recruited 109 randomized to fish oil, and 107 to soybean oil. Completion rate was 86/109 (78.9%) and 96/107 (89.7%) respectively. At the end of week-8 of follow up most participants in both arms had mild depressive symptoms 82/86 (95.3%) in the Fish oil group and 94/96 (97.9%) in the Soybean oil group. The difference in effect between the intervention and control group was not statistically significant (1.01 (95% CI - 0.58 to 2.60), p = 0.21).

Conclusion: Fish oil omega-3 with a daily dosage of 3.17 g (eicosapentaenoic acid = 2.15 g; docosahexaenoic acid = 1.02 g) appears to provide no added benefit in reduction of the symptoms of depression in HIV-infected pregnant women.Trial Registration Clinical Trial Registry: NCT01614249. Registered on June 5, 2012. https://ichgcp.net/clinical-trials-registry/NCT01614249.

Keywords: Depression; Fish oil; HIV infection; Omega-3; Pregnancy; RCT.

Figures

Fig. 1
Fig. 1
Participants’ distribution and flow during the trial based on the Consolidated Standards of Reporting Trials. The participants’ distribution and flow during the trial based on the Consolidated Standards of Reporting Trials [52]. It indicates total number of study participants who were recruited (N = 282), excluded from enrolment based on exclusion criteria (N = 66), enrolled for the 8-week study (fish oil arm = 109; soybean oil arm = 107), dropped out before the 8 weeks (fish oil arm = 23; soybean oil = 11) and those who completed the 8-week trial period and were included in the analysis (fish oil = 86; soybean oil = 96).The difference in completion between the two groups was, however, not significant at the end of study (X2(1) = 1.64; p value = 0.20), and did not significantly influence the change in BDI-II depressive symptom scores in fish oil (0.41 (95% CI − 4.49 to 5.32), p = 0.87) and soybean oil (− 3.21 (95% CI − 13.18 to 6.76), p = 0.52) groups
Fig. 2
Fig. 2
Quantile–quantile plot normality test for change in BDI-II scores by study arm The quantile–quantile plot normality statistical test for change in BDI-II depressive symptom scores conducted showed that the scores were normally distributed after 4 weeks: fish oil, N = 92; soybean oil, N = 98; and after 8 weeks: fish oil, N = 86; soybean oil—N = 96). Any variability present in the distribution of the scores in the samples was not statistically significant, based on Levene’s test of variance for sample means of the change in scores after 4 weeks (F (1188) = 0.79, p = 0.37; medians (F (1180) = 0.80, p = 0.37) and after 8 weeks (F (1180) = 1.96 p = 0.16); medians (F (1180) = 1.45, p = 0.23) and standard deviation test of variance (p = 0.24). Variability in errors across observations was controlled for through robust analysis method. Hence, the change in BDI-II depressive symptom scores met the regression analysis assumptions of normality
Fig. 3
Fig. 3
95% confidence interval bars for change in BDI-II scores by study arm and period. The calculated 95% confidence intervals (CI) for the mean difference in the change in BDI-II scores between the two intervention groups overlapped substantially after 4 weeks (Fish oil (N = 92). 95% CI − 12.3 to − 9.3; soybean oil (N = 98), 95% CI − 12.3 to − 10.2) and after 8 weeks (Fish oil (N = 86), 95% CI − 14.9 to − 12.0; soybean oil (N = 96), 95% CI − 15.3 to − 12.6). This overlap suggested that there was no significant difference in intervention effect on depressive symptoms between the two study groups

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