Skip to main content
OpenTrials
Completed

NCT Number: NCT04158869

An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents

This is an observational case-control add-on study to an investigator-initiated clinical trial (IICT) (ClinicalTrials.gov Identifier: NCT03167307): Omega-3 fatty acids as firstline treatment in pediatric depression. A 36-week multi-centre, double-blind, placebo-controlled randomized superiority study.

This project will recruit a healthy control group matched for age and sex to a sub-group of patients with diagnosed pediatric major depressive disorder (pMDD) enrolled in the IICT. The aim is to investigate the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD, and explore potential biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health and cognitive function.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ETH Zürich

Zurich, 8092, Switzerland

About this study

According to a recent school survey, one out of ten adolescents in Zurich have moderate to marked depressive symptoms. Early onset of paediatric major depressive disorder (pMDD) is a risk factor for chronic and recurrent forms of depression in adulthood (MDD). MDD is associated with difficulties in relationships, impaired school and work performance, and an increased risk of substance abuse. Furthermore, MDD is a major contributor to the burden of suicide and poor long-term health late in life. The emerging potential of n-3 polyunsaturated fatty acids (n-3 PUFAs), also known in short as omega-3 fatty acids (n-3 FAs), for the treatment of MDD is being investigated in several studies. Previous observational studies suggest a link between the consumption of n-3PUFA-rich food and the level of depressive symptoms. However, studies that investigated the potential beneficial effects of n-3 PUFA supplementation for the treatment of MDD compared with placebo showed inconsistent findings.

Primary objectives of this project are:

  • To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.
  • To explore biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health, cognitive function, and potential pathways linking n-3 FA intake/status and brain health (e.g. immune system, gut microbiome-brain-axis).

Participants meeting the following criteria are eligible for the study:

Inclusion criteria

  • Participants of female and male sex
  • Children aged 8 to ≤ 13 years or teenagers 13 to < 18 years at time of study entry
  • Written informed assent of the subject and written informed consent from the subject's parents/legal representatives
  • No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test

Exclusion criteria

  • More than 4 weeks of regular n-3 FA supplementation
  • Women who are self-reported pregnant or breast feeding
  • Pre-existing neurological or medical conditions likely to be a risk factor for developing depressive symptoms

In a first step participants will be screened for in- and exclusion criteria. If participants can be included into the study we will

  • Measure participant's mental health with behavioural and cognitive assessments
  • Collect biological samples from participants (blood, urine, saliva, hair, and stool)

This study aims to recruit a total of 200 participants: 100 cases (from IICT) and 100 controls (recruited for this study).

There will be a total recruiting period of 18 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For cases: participants enrolled in the IICT and therefore meeting the criterie for participation in the IICT will be selected.

For controls, participants fulfilling all of the following inlclusion criterie are eligible for the study

Inclusion criteria

  • Participants of female and male sex
  • Children aged 8 to ≤ 13 years or teenagers 13 to < 18 years at time of study entry
  • Written informed assent of the subject (appendix informed consent forms) and written in formed consent form from the subjects' parents/legal representatives
  • No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test.
  • No use of chronic medication
  • Able to communicate in German; degree of understanding sufficient to comply with trial procedure

Exclusion criteria

  • More than 4 weeks of regular n-3 FA supplementation (>2 daily capsules standard strength providing > 600 mg combined EPA/DHA) within the last 6 months.
  • Women who are self-reported pregnant or breast feeding.
  • Self-reported pre-existing neurological (such as e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy) or medical conditions (ICD-10 F06-F07) likely to be a risk factor for developing depressive symptoms
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Treatment and study plan

Primary outcomes

  1. n-3 fatty acid intake

    Time frame: 6 months

    Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire

  2. n-3 fatty acid status

    Time frame: 1 day

    Measurement of relative amount of n-3 fatty acids

  3. Pediatric depressive symptoms

    Time frame: 2 weeks

    Quantification of depressive symptoms with "Children's Depression Rating Scale - Revised" (CDRS-R) total score; Scale from 17 to >72; values >40 rated as moderate depression

Secondary outcomes

  1. Fatty acid metabolism

    Time frame: 1 day

    Measurement of lipid mediators

  2. Biomarkers related to brain health

    Time frame: 1 day

    Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters

  3. Biomarkers related to systemic inflammation

    Time frame: 1 day

    Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines

  4. Biomarkers related to gut microbiota

    Time frame: 1 day

    Measurement of

    • gut microbiome composition with 16S rRNA sequencing
    • Faecal calprotectin
    • Intestinal fatty acid binding protein
  5. Biomarkers related to nutritional status

    Time frame: 1 day

    Measurement of iron and iodine status

Other outcomes

  1. Verbal learning and memory test (VLMT)

    Time frame: 1 day

    Differences in scores between cases and controls

  2. Behavior Rating Inventory of Executive Function (BRIEF)

    Time frame: 1 day

    Differences in the overall score between cases and controls

  3. Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV)

    Time frame: 1 day

    Differences in scores between cases and controls

  4. Emotion recognition measured with the Amsterdam Neuropsychological Task (ANT) program

    Time frame: 1 day

    Differences in scores between cases and controls

  5. Attentional flexibility measured with the shifting attentional set of the Amsterdam Neuropsychological Task (ANT) program

    Time frame: 1 day

    Differences in reaction times between cases and controls

  6. Regensburg Word Fluency Test (RWT)

    Time frame: 1 day

    Differences in scores between cases and controls

  7. Reynolds Intellectual Assessment Scales (RIAS)

    Time frame: 1 day

    Differences in scores between cases and controls

  8. Suicidal ideation Questionnaire (SIQ)

    Time frame: 1 month

    Differences in scores between cases and controls

  9. Scale of Impulsivity and Emotion Dysregulation (IES-27)

    Time frame: 1 month

    Differences in scores between cases and controls

  10. Childhood Trauma Questionnaire (CTQ)

    Time frame: 1 day

    Differences in scores between cases and controls

  11. Strenght and Difficulty Questionnaire (SDQ)

    Time frame: 1 day

    Differences in scores between cases and controls

  12. Perceived Stress Scale (PSS-10)

    Time frame: 1 month

    Differences in scores between cases and controls

  13. Children's Depression Inventory (DIKJ)

    Time frame: 1 month

    Differences in scores between cases and controls

  14. Connor Davidson Resilience Scale (CDRS)

    Time frame: 1 month

    Differences in scores between cases and controls

  15. Beck Anxiety Inventory (BAI)

    Time frame: 1 month

    Differences in scores between cases and controls

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Psychiatric University Hospital, Zurich

Registry information

Official study title

An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.