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01-12-2020 | Mood Disorders | Study protocol

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)

Authors: Hayley A. Bradley, Siobhan A. Campbell, Roger T. Mulder, Jaqueline M. T. Henderson, Lesley Dixon, Joseph M. Boden, Julia J. Rucklidge

Published in: BMC Pregnancy and Childbirth | Issue 1/2020

Abstract

Background

Untreated antenatal depression and anxiety can be associated with short and long term health impacts on the pregnant woman, her infant and the rest of the family. Alternative interventions to those currently available are needed. This clinical trial aims to investigate the efficacy and safety of a broad-spectrum multinutrient formula as a treatment for symptoms of depression and anxiety in pregnant women and to determine the impact supplementation has on the general health and development of the infant.

Methods

This randomised, controlled trial will be conducted in Canterbury, New Zealand between April 2017 and June 2022. One hundred and twenty women aged over 16 years, between 12 and 24 weeks gestation and who score ≥ 13 on the Edinburgh Postnatal Depression Scale (EPDS) will be randomly assigned to take the intervention (n = 60) or an active control formula containing iodine and riboflavin (n = 60) for 12 weeks. After 12 weeks, participants can enter an open-label phase until the birth of their infant and naturalistically followed for the first 12 months postpartum. Infants will be followed until 12 months of age. Randomisation will be computer-generated, with allocation concealment by opaque sequentially numbered envelopes. Participants and the research team including data analysts will be blinded to group assignment. The EPDS and the Clinical Global Impressions Scale of Improvement (CGI-I) will be the maternal primary outcome measures of this study and will assess the incidence of depression and anxiety and the improvement of symptomatology respectively. Generalized linear mixed effects regression models will analyse statistical differences between the multinutrient and active control group on an intent-to-treat basis. A minimum of a three-point difference in EPDS scores between the groups will identify clinical significance. Pregnancy outcomes, adverse events and side effects will also be monitored and reported.

Discussion

Should the multinutrient formula be shown to be beneficial for both the mother and the infant, then an alternative treatment option that may also improve the biopsychosocial development of their infants can be provided for pregnant women experiencing symptoms of depression and anxiety.

Trial registration

Trial ID: ACTRN12617000354381; prospectively registered at Australian New Zealand Clinical Trials Registry on 08/03/2017.

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Title: 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)
Authors: Hayley A. Bradley
Siobhan A. Campbell
Roger T. Mulder
Jaqueline M. T. Henderson
Lesley Dixon
Joseph M. Boden
Julia J. Rucklidge
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Mood Disorders
Affective Disorder
Anxiety
Published in: BMC Pregnancy and Childbirth / Issue 1/2020
Electronic ISSN: 1471-2393
DOI: https://doi.org/10.1186/s12884-020-03143-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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)

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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