NCT02498106

Brief Summary

The overall goal of this study is to investigate whether the daily administration of multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric inpatients and will thereby reduce costs of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.4 years

First QC Date

July 9, 2015

Last Update Submit

October 31, 2019

Conditions

Psychiatric Hospitalization

Keywords

nutritionaggressionn-3 fatty acidspsychiatryinpatients admitted >2 years

Outcome Measures

Primary Outcomes (1)

  • Number of aggressive incidents

    The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3), as registered daily on the ward by nurses using the Dutch version of the Staff Observation Aggression Scale- Revised version (SOAS-R)

    daily for the total duration of the (six-month) intervention period

Secondary Outcomes (4)

  • Patient feelings of aggression

    At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

  • Patient quality of life

    At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

  • Patient psychiatric symptoms

    At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

  • Observed patient social dysfunction

    At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3])

Other Outcomes (1)

  • Patient micronutrient status

    At 2 points (baseline [t0] and six months post baseline [t3])

Study Arms (2)

nutritional supplement

ACTIVE COMPARATOR

2 Orthica Soft Multi Mini capsules and 1 Orthica Fish EPA Mini capsule per day; duration: 6 months

Dietary Supplement: Orthica Soft Multi Mini and Orthica Fish EPA Mini

placebo

PLACEBO COMPARATOR

During 6 months one group receives 3 placebo supplements daily with identical look and feel to Orthica Soft Multi Mini and Orthica Fish EPA Mini

Dietary Supplement: Orthica Soft Multi Mini and Orthica Fish EPA Mini

Interventions

Orthica Soft Multi Mini and Orthica Fish EPA MiniDIETARY_SUPPLEMENT

daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene\] and minerals \[Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese\]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\])

nutritional supplementplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residing at a facility for long-term psychiatric inpatient care
  • age 18 or over

You may not qualify if:

  • pregnancy
  • breastfeeding
  • known contra-indication for using the supplements used in this study
  • expected discharge or transfer within the next 8 weeks
  • current use of dietary supplements and refusal to stop using these for the duration of the study
  • failure to complete run-in phase
  • contra-indication for the use of pork-gelatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GGZ Centraal

Ermelo, Gelderland, 3853 LC, Netherlands

Location

GGZ Eindhoven

Eindhoven, Noord-Braband, 5626 ND, Netherlands

Location

GGZ Delfland

Delft, South Holland, Netherlands

Location

Fivoor

Den Dolder, Utrecht, 3734 AC, Netherlands

Location

Rivierduinen

Oegstgeest, 2342 EB, Netherlands

Location

Parnassia

The Hague, 2512 HN, Netherlands

Location

Related Publications (10)

  • Hornsveld RH, Muris P, Kraaimaat FW, Meesters C. Psychometric properties of the aggression questionnaire in Dutch violent forensic psychiatric patients and secondary vocational students. Assessment. 2009 Jun;16(2):181-92. doi: 10.1177/1073191108325894. Epub 2008 Oct 13.

    PMID: 18852480BACKGROUND

  • Nijman H, Palmstierna T. Measuring aggression with the staff observation aggression scale--revised. Acta Psychiatr Scand Suppl. 2002;(412):101-2. doi: 10.1034/j.1600-0447.106.s412.21.x.

    PMID: 12072137BACKGROUND

  • Asberg M, Schalling D. Construction of a new psychiatric rating instrument, the Comprehensive Psychopathological Rating Scale (CPRS). Prog Neuropsychopharmacol. 1979;3(4):405-12. doi: 10.1016/0364-7722(79)90055-9.

    PMID: 400996BACKGROUND

  • Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

    PMID: 15085902BACKGROUND

  • Schoenthaler SJ, Bier ID. The effect of vitamin-mineral supplementation on juvenile delinquency among American schoolchildren: a randomized, double-blind placebo-controlled trial. J Altern Complement Med. 2000 Feb;6(1):7-17. doi: 10.1089/acm.2000.6.7.

    PMID: 10706231BACKGROUND

  • Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.

    PMID: 12091259BACKGROUND

  • Zaalberg A, Nijman H, Bulten E, Stroosma L, van der Staak C. Effects of nutritional supplements on aggression, rule-breaking, and psychopathology among young adult prisoners. Aggress Behav. 2010 Mar-Apr;36(2):117-26. doi: 10.1002/ab.20335.

    PMID: 20014286BACKGROUND

  • Legare N, Brosseau E, Joyal CC. Omega-3 and violence in schizophrenia. Schizophr Res. 2007 Nov;96(1-3):269. doi: 10.1016/j.schres.2007.05.023. Epub 2007 Jul 16. No abstract available.

    PMID: 17629678BACKGROUND

  • Benton D. The impact of diet on anti-social, violent and criminal behaviour. Neurosci Biobehav Rev. 2007;31(5):752-74. doi: 10.1016/j.neubiorev.2007.02.002. Epub 2007 Mar 4.

    PMID: 17433442BACKGROUND

  • de Bles NJ, Gast DAA, van der Slot AJC, Didden R, van Hemert AM, Rius-Ottenheim N, Giltay EJ. Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour. J Eval Clin Pract. 2022 Aug;28(4):607-614. doi: 10.1111/jep.13653. Epub 2022 Jan 17.

    PMID: 35040231DERIVED

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Erik J. Giltay, MD PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Erik J. Giltay, MD, PhD

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 15, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

NL(6)