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Table 2 Trial registration data

From: Can broad-spectrum multinutrients treat symptoms of antenatal depression and anxiety and improve infant development? Study protocol of a double blind, randomized, controlled trial (the ‘NUTRIMUM’ trial)

Data category Trial information
Primary registry and trial identification number Australian and New Zealand Clinical Trials Registry; ACTRN12617000354381
Date of registration in primary registry 8 March 2017
Secondary identifying numbers Universal Trial Number (UTN): U1111–1189-4070
Source(s) of monetary or material support Hardy Nutritionals, Department of Psychology Research Funds, University of Canterbury; University of Canterbury Foundation; Foundation for Excellence in Mental Health Care; The Nurture Foundation for Reproductive Research; St George’s Hospital, NZ, Canterbury Medical Research Foundation,
Primary sponsor Prof Julia Rucklidge
Secondary sponsor(s) Prof Roger Mulder, Dr. Jacqueline Henderson, Prof Martin Kennedy, Dr. Kyle Nash, Dr. Lesley Dixon, A/P Joseph Boden, Hayley Bradley
Contact for public enquiries Hayley Bradley, hayley.bradley@pg.canterbury.ac.nz
Contact for scientific enquiries Prof Julia Rucklidge, julia.rucklidge@canterbury.ac.nz
Public title A multinutrient intervention for pregnant women experiencing symptoms of depression and anxiety.
Scientific title An investigation examining the efficacy and safety of a multinutrient intervention on symptoms of antenatal depression and anxiety in pregnant women who are symptomatic: A double blind, randomized, controlled trial.
Countries of recruitment New Zealand
Health condition(s) or problem(s) studied Depression, anxiety
Interventions Intervention: Daily Essential Nutrients (12 capsules per day)
Active control: Iodine and Riboflavin (12 capsules per day)
Key inclusion and exclusion criteria Ages eligible for study: ≥16 years; Sexes available for study: femaleAccepts healthy volunteers: no
Inclusion criteria: women aged 16 years and over; 12–24 weeks gestation; low risk singleton pregnancy; free from psychiatric medication for four weeks; score of 13 or more on the Edinburgh Postnatal Depression Scale (EPDS); deemed reliable and compliant with the protocol
Exclusion criteria: regular vomiting; high risk pregnancy; significant pregnancy complications; known foetal abnormalities; serious current or historical medical condition; known allergy to the ingredients of the intervention; known metabolic condition such as Wilson’s disease, hemochromatosis.; untreated or unstable thyroid disease; known neurological disorder; desire to continue taking prenatal supplements that either exceed the upper limit or are not required for medical purposes (decisions discussed and made on a case-by-case basis)
Study type Interventional
Allocation: randomised, parallel assignment; Masking: blinding of people taking and administering the treatment, assessing the outcomes and analysing the results / data
Primary purpose: treatment
Date of first enrolment 12 April 2017
Target sample size 120
Recruitment status Recruiting
Primary outcome(s) Depression and anxiety; Edinburgh Postnatal Depression Scale (time points: screening, baseline, every two weeks until birth and at 1 month and 6 months postpartum)
Symptom improvement; Clinical Global Impressions Scale – Improvement (time points: baseline, every four weeks until birth and at 1 month and 6 months postpartum)
Key secondary outcomes Depression; The Montgomery and Asberg Depression Rating Scale (time points: baseline, every four weeks until birth and at 1 month and 6 months postpartum)
Anxiety; Generalized Anxiety Disorder – 7 (time points: baseline, every two weeks until birth and at 1 month and 6 months postpartum)
Depression, Anxiety, Stress; Depression, Anxiety, Stress Scale – 21 (time points: baseline, every two weeks until birth and at 1 month and 6 months postpartum)
Sleep quality; The Pittsburgh Sleep Quality Index (time points: baseline, every four weeks until birth and at 1 month and 6 months postpartum)
Quality of life; Short Form Health Survey – 12 (time points: baseline, every four weeks until birth and at 1 month and 6 months postpartum)
Emotion dysregulation; Difficulties in Emotion Regulation Scale - Short Form (time points: baseline, every four weeks until birth and at 1 month and 6 months postpartum)
Side effects; Antidepressant Side-Effect Checklist, (time points: baseline, every two weeks until birth and at 1 month and 6 months postpartum)
Plasma nutrient levels (vitamin C, vitamin B12, vitamin D, copper, zinc, iron and homocysteine) (time points: baseline and 12 weeks)
Inflammatory biomarkers (interleukin – 6, tumor necrosis factor - alpha, interleukin-4 and interleukin-10) (time points: baseline and 12 weeks)
Anxiety related endophenotypes and neurophysiological markers; Electroencephalography (time points: baseline and 12 weeks)
Microbiome; faecal samples (time points: baseline and 12 weeks)