Clinical trial NCT02498106: Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation
Official title: Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Supplementation of Multivitamins, Minerals and n-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Hospitalization
Keywords: nutrition
aggression
n-3 fatty acids
psychiatry
inpatients admitted >2 years
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Atrium Innovations
First posted: 2015-07-15
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Aggressive incidents are highly prevalent among chronic psychiatric inpatients. Previous studies have demonstrated the potential of multivitamin-, mineral-, and n-3 fatty acids (n-3FA) supplementation to reduce aggression in adolescent and forensic populations. To test the hypothesis that multivitamin-, mineral-, and n-3FA supplementation reduces aggression among chronic psychiatric inpatients, we designed a pragmatic, randomised, double-blind, placebo controlled, multicentre intervention study among psychiatric inpatients residing in long-stay psychiatric wards. During 6 months, one group receives 2 supplements daily from Orthica: one containing vitamins and minerals (vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene; Calcium, Iodine, Copper, Magnesium, Selenium, Iron, Zinc, Potassium, Chrome, Manganese\]) and one containing fish fatty acids (n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\]) and the other group receives 2 placebo capsules.

The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3). Patients who wish to participate enter a 2-week run-in phase in which they take 2 placebo capsules daily. After positive evaluation of this run-in phase patients are randomized to the active or the control condition. Participants will then start the daily use of 2 supplement capsules or 2 placebo capsules, which will continue for 6 months. At 3 time points (at baseline \[t0\] and at 2 and 6 months post-baseline \[t2 and t3\]), three questionnaires measuring feelings of aggression, quality of life, and psychiatric symptoms will be administered. Also, at t0 and t3 (micro)nutrient status will be determined. Finally, at 4 time points (t0, 2 weeks post baseline \[t1\], t2 and t3), nursing staff will report on observed levels of aggression and social dysfunction.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of aggressive incidents
timeFrame: daily for the total duration of the (six-month) intervention period
Secondary outcomes:
measure: Patient feelings of aggression
timeFrame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
measure: Patient quality of life
timeFrame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
measure: Patient psychiatric symptoms
timeFrame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
measure: Observed patient social dysfunction
timeFrame: At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3])
Other outcomes:
measure: Patient micronutrient status
timeFrame: At 2 points (baseline [t0] and six months post baseline [t3])
Locations:
city: Ermelo
country: Netherlands
facility: GGZ Centraal
state: Gelderland
city: Eindhoven
country: Netherlands
facility: GGZ Eindhoven
state: Noord-Braband
city: Den Dolder
country: Netherlands
facility: Fivoor
state: Utrecht
city: Delft
country: Netherlands
facility: GGZ Delfland
state: Zuid-Holland
city: Oegstgeest
country: Netherlands
facility: Rivierduinen
city: The Hague
country: Netherlands
facility: Parnassia
Study officials:
affiliation: Leiden University Medical Center
name: Erik J. Giltay, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.