Can a broad-spectrum micronutrient formula improve symptoms of antenatal depression? : a double blind, randomized, active placebo-controlled trial (the ‘NUTRIMUM’ trial)

Background: Left untreated, antenatal depression can have negative consequences for the pregnant woman and her baby and alternative treatments to those currently recommended are needed. A growing body of evidence for broad-spectrum micronutrients (vitamins and minerals) is showing promise as a treatment for a range of mental health difficulties, including dysregulated mood and depressive symptoms. This thesis presents outcomes from a fully-blind, randomised controlled trial investigating the efficacy and safety of a broad-spectrum micronutrient (minerals and vitamins) formula for the treatment of depressive symptoms during pregnancy. Methods: A total of 88 pregnant women who were between 12-24 weeks gestation, had a low risk singleton pregnancy, scored ≥13 on the Edinburgh Postnatal Depression Scale (EPDS) and were not concurrently taking psychiatric medication were randomised to either a broad-spectrum micronutrient formula (n=44) or an active placebo, containing iodine and riboflavin (n=44), for twelve-weeks. The primary outcome measures included the clinician-rated Clinical Global Impression Scale of Improvement (CGI-I) and the EPDS, a patient measure of depression. Secondary measures examined depression, anxiety, stress, sleep quality, health-related quality of life, emotion dysregulation and impairments in functioning. All primary and secondary measures were analysed by an independent statistician who was blind to treatment allocation using mixed effects linear modelling. Inflammatory biomarkers were obtained to understand the mechanisms via which micronutrients may exert their effect on mood. Adverse events, haematology results and biometric data were reported to determine the safety of the intervention. Results: Seventeen (19%) participants withdrew from the trial with no differences in dropouts and four (4.5%) birthed before the end of the trial, such that 67 participants (76%) completed the full twelve-weeks of the trial. Based on the CGI-I, the micronutrient group demonstrated significantly greater improvement in symptoms over the course of the trial in comparison to the active placebo group (p