Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation

Psychiatric Hospitalization Clinical Trial

Official title:

Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Supplementation of Multivitamins, Minerals and n-3 Fatty Acids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498106
• Other study ID #: P14.332
• Secondary ID: 836031016NL51850
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Psychiatric Hospitalization

Intervention

Dietary Supplement:
• Orthica Soft Multi Mini and Orthica Fish EPA Mini
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])

Locations

Country	Name	City	State
Netherlands	GGZ Delfland	Delft	Zuid-Holland
Netherlands	Fivoor	Den Dolder	Utrecht
Netherlands	GGZ Eindhoven	Eindhoven	Noord-Braband
Netherlands	GGZ Centraal	Ermelo	Gelderland
Netherlands	Rivierduinen	Oegstgeest
Netherlands	Parnassia	The Hague

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Atrium Innovations

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

Asberg M, Schalling D. Construction of a new psychiatric rating instrument, the Comprehensive Psychopathological Rating Scale (CPRS). Prog Neuropsychopharmacol. 1979;3(4):405-12. — View Citation

Benton D. The impact of diet on anti-social, violent and criminal behaviour. Neurosci Biobehav Rev. 2007;31(5):752-74. Epub 2007 Mar 4. Review. — View 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. — View Citation

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. — View Citation

Légaré N, Brosseau E, Joyal CC. Omega-3 and violence in schizophrenia. Schizophr Res. 2007 Nov;96(1-3):269. Epub 2007 Jul 16. — View Citation

Nijman H, Palmstierna T. Measuring aggression with the staff observation aggression scale--revised. Acta Psychiatr Scand Suppl. 2002;(412):101-2. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient micronutrient status	Blood samples (50cc) will be taken to determine micronutrient status, including Vitamins A, E, B1, B6, B12, D, and folate, total iron, magnesium, and the fatty acid spectrum.	At 2 points (baseline [t0] and six months post baseline [t3])
Primary	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	Patient feelings of aggression	the Aangepaste Versie van de Agressievragenlijst (AVL-AV, 1), a 12 item self-report questionnaire about feelings of aggression.	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
Secondary	Patient quality of life	the World Health Organization Quality of Life Questionnaire (WHO-QL-bref 5), a 26-item observer rated quality of life instrument.	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
Secondary	Patient psychiatric symptoms	The verkorte Comprehensive Psychopathological Rating Scale (vCPRS), a 25-item observer rated instrument on affective symptoms, which includes the Montgomery-Åsberg Depression Rating Scale (MADRS).	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])
Secondary	Observed patient social dysfunction	Nursing staff will fill in the Social Dysfunction Aggression Scale (SDAS), measuring observed levels of aggression and social dysfunction.	At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3])