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

• ClinicalTrials.gov Identifier: NCT02498106
• Recruitment Status: Completed
• First Posted: July 15, 2015
• Last Update Posted: November 1, 2019
• Sponsor: Leiden University Medical Center
• Collaborator: Atrium Innovations
• Information provided by (Responsible Party): Erik J. Giltay, MD, PhD, Leiden University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psychiatric Hospitalization	Dietary Supplement: Orthica Soft Multi Mini and Orthica Fish EPA Mini	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Supplementation of Multivitamins, Minerals and n-3 Fatty Acids
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: October 2019
• Actual Study Completion Date: October 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: nutritional supplement; 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; 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])
Placebo Comparator: placebo; 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; 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])

Outcome Measures

Primary Outcome Measures :

1. Number of aggressive incidents [ Time Frame: daily for the total duration of the (six-month) intervention period ]
   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)

Secondary Outcome Measures :

1. Patient feelings of aggression [ Time Frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3]) ]
   the Aangepaste Versie van de Agressievragenlijst (AVL-AV, 1), a 12 item self-report questionnaire about feelings of aggression.
2. Patient quality of life [ Time Frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3]) ]
   the World Health Organization Quality of Life Questionnaire (WHO-QL-bref 5), a 26-item observer rated quality of life instrument.
3. Patient psychiatric symptoms [ Time Frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3]) ]
   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).
4. Observed patient social dysfunction [ Time Frame: At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3]) ]
   Nursing staff will fill in the Social Dysfunction Aggression Scale (SDAS), measuring observed levels of aggression and social dysfunction.

Other Outcome Measures:

1. Patient micronutrient status [ Time Frame: At 2 points (baseline [t0] and six months post baseline [t3]) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

GGZ Centraal

Ermelo, Gelderland, Netherlands, 3853 LC

GGZ Eindhoven

Eindhoven, Noord-Braband, Netherlands, 5626 ND

Fivoor

Den Dolder, Utrecht, Netherlands, 3734 AC

GGZ Delfland

Delft, Zuid-Holland, Netherlands

Rivierduinen

Oegstgeest, Netherlands, 2342 EB

Parnassia

The Hague, Netherlands, 2512 HN

Sponsors and Collaborators

Leiden University Medical Center

Atrium Innovations

Investigators

• Principal Investigator: Erik J. Giltay, MD PhD; Leiden University Medical Center

More Information

Publications:

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.

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

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

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.

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.

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.

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.

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

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.

• Responsible Party: Erik J. Giltay, MD, PhD, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT02498106
• Other Study ID Numbers: P14.332; 836031016 ( Other Grant/Funding Number: ZonMW ); NL51850.058.14 ( Registry Identifier: Toetsing online ); 5176 ( Registry Identifier: NTR )
• First Posted: July 15, 2015
• Last Update Posted: November 1, 2019
• Last Verified: October 2019

Keywords provided by Erik J. Giltay, MD, PhD, Leiden University Medical Center:

nutrition; aggression; n-3 fatty acids; psychiatry; inpatients admitted >2 years

Additional relevant MeSH terms:

Aggression; Behavioral Symptoms