Condition category
Mental and Behavioural Disorders
Date applied
22/09/2008
Date assigned
30/09/2008
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rgu.ac.uk/fhsc/core/page.cfm?pge=45441

Contact information

Type

Scientific

Primary contact

Prof Iain Broom

ORCID ID

Contact details

The Centre for Obesity Research and Epidemiology
The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom
+44 (0)1224 262895
j.broom@rgu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The relationship between nutrition, increased inflammation and depression in pregnancy and post-partum: assessment of depression scores, inflammatory cytokines and omega-3 fatty acids

Acronym

DIO-3

Study hypothesis

Psychological stress and depression increase the production of pro-inflammatory cytokines, and reduce the production of anti-inflammatory/immuno-regulatory cytokines. An increased ratio of omega-6 to omega-3 polyunsaturated fatty acids (PUFAs) in the blood causes an increase in the production of pro-inflammatory cytokines and a reduction in the production of anti-inflammatory cytokines. Population studies have found an inverse relationship between depression and per capita fish consumption; and lower blood/plasma omega-3 FA content has been found in subjects with depression.

Pregnancy and post-partum are associated with immune activation and hypersecretion of pro-inflammatory cytokines and elevated C-reactive protein. Studies have reported low blood omega-3 FA levels in pregnancy and post-partum. Psychological stress and depression are prevalent in pregnancy. Psycho-social risk factors known to be associated with depression increase the prevalence of depression in pregnancy. A higher omega-6 to omega-3 ratio may predict an increase in the production of pro-inflammatory cytokines to psychological stress and depression.

The aim of this study is to investigate the relationship between maternal omega-3 and omega-6 PUFA status (evaluated by the food frequency questionnaire [FFQ] and erythrocyte membrane FA), inflammatory cytokines and depression during pregnancy and post-partum in women at high-risk of depression (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression; and to assess the potential for the development of specific biomarkers to predict the onset and progression of this condition.

Ethics approval

The North of Scotland Research Ethics Committee, 11th June 2008 (REC Ref: 08/S0801/21)

Study design

Observational prospective (longitudinal) cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Maternal stress and depression

Intervention

This is an observational prospective longitudinal (from first trimester of pregnancy to 6 months post-partum) cohort study, where the data concerning the condition are assembled and observed prior to the condition occurring and when the condition occurs. Patients without depression, but identified as high-risk (psycho-social history of exposure) and low-risk of depression (no psycho-social history of exposure) will be followed and observed for depression, increased inflammation and high omega-6 to omega-3 ratio. The following data will be collected:
1. Assessment of risk factors known to be associated with perinatal depression (Antenatal Risk Questionnaire [ANRQ]; Postnatal Risk Questionnaire [PNRQ])
2. Assessment of perinatal psychological stress and depression (Edinburgh Depression Scale/Edinburgh Postnatal Depression Scale [EDS/EPDS]; Hospital and Anxiety Depression Scale [HADS])
3. Assessment of dietary omega-3 and omega-6 FAs (Scottish Collaborative Group Food Frequency Questionnaire [SCGFFQ])
4. Assessment of erythrocyte membrane omega-3 and omega-6 FA content
5. Assessment of serum inflammatory cytokines
6. Assessment of plasma C-reactive protein

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Differences in depression scores, inflammatory cytokines and CRP concentrations and omega-3 FA status between women at high-risk (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression
2. Correlations between omega-6 to omega-3 FA ratio, inflammatory cytokines and CRP concentrations and depression scores

Time points:
1. Baseline (13 weeks gestation)
2. 24 weeks gestation
3. 34 weeks gestation
4. 36 hours post-delivery
5. 6 weeks post-partum
6. 12 weeks post-partum
7. 24 weeks post-partum

Secondary outcome measures

1. Incidence of depression in women at high-risk of depression (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression (measured by the ANRQ and PNRQ) (the ANRQ is used only at baseline; the PNRQ is used only at 36 hours post-delivery)
2. Comparison of depression scores measured by the EDP/EPDS and the HADS
3. Comparison of omega-3 and omega-6 FA intakes measured by the SCGFFQ and erythrocyte membrane content

Time points:
1. Baseline (13 weeks gestation)
2. 24 weeks gestation
3. 34 weeks gestation
4. 36 hours post-delivery
5. 6 weeks post-partum
6. 12 weeks post-partum
7. 24 weeks post-partum

Overall trial start date

03/11/2008

Overall trial end date

25/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnancy and post-partum
2. Age 18 - 45 years
3. Healthy volunteers
4. Patient under Grampian Healthcare

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Medical conditions (including obstetric complications) or currently taking medication affecting the immune, endocrine (thyroid dysfunction, diabetes), metabolic, hepatic, renal, and gastrointestinal systems; coagulation disorders and anaemia
2. A history of psychiatric disorders other than depression (mania/hypomania, psychosis, active suicidal ideation, schizophrenia, eating disorders not associated with depression, personality disorders, epilepsy)
3. Taking anti-depressant medication or other remedies for depression (St Johns Wort)
4. A history of alcohol or drug abuse, and tobacco use
5. Assisted conception
6. Taking supplementary fish oils or flax seed
8. Spontaneous miscarriage and termination of pregnancy

Recruitment start date

03/11/2008

Recruitment end date

25/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Centre for Obesity Research and Epidemiology
Aberdeen
AB25 1HG
United Kingdom

Sponsor information

Organisation

The Centre for Obesity Research and Epidemiology (CORE) (UK)

Sponsor details

The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom
+44 (0)1224 262641
j.broom@rgu.ac.uk

Sponsor type

Research organisation

Website

http://www.rgu.ac.uk/acero/CORE/

Funders

Funder type

Research organisation

Funder name

The Centre for Obesity Research and Epidemiology (CORE) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/06/2016: No publications found, verifying study status with principal investigator