NCT02498106

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychiatric Hospitalization

Interventions

Type	Name	Description
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 \[DHA\])

Timeline

• Start date: 2015-05-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2015-07-15
• Last updated: 2019-11-01

Locations

6 sites across 1 country: Netherlands