Table 2 Trial registration data

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)