Reducing Aggression Among People With an Intellectual Disability

Intellectual Disability Clinical Trial

— PSYVB  

Official title:

Reducing Aggressive Behaviour Among People With an Intellectual Disability Through Supplementation of Vitamins, Minerals and n-3 Fatty Acids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212092
• Other study ID #: NL60839.058.17
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is an randomised controlled trial (RCT) to test whether supplementation of vitamins, minerals and n-3 fatty acids may reduce aggressive behavior in people with intellectual disabilities.

Description:

Rationale: The prevalence of aggression among people with an intellectual disability is high. Previous studies have demonstrated the potential of multivitamin-, mineral-, and n-3 fatty acids (n-3FA) supplementation to reduce antisocial behavior and aggression among schoolchildren and prisoners.

Objective: To test the hypothesis that multivitamin-, mineral-, and n-3 FA supplementation reduces aggression among adolescents and young adults with an intellectual disability.

Study design: Pragmatic, randomised, double blind, placebo controlled, multicentre intervention study.

Study population: People with an intellectual disability aged between 12-39 years, living at a care or treatment facility or having day care, who have shown aggressive behaviour.

Intervention: During 16 weeks, people in the active condition receive 4 supplements daily: 2 Bonusan Multi Vital Forte Actief (Multi vitamin and mineral) and 2 Bonusan Omega-3 Forte (n-3 fatty acids) while people in the placebo condition receive 4 placebo capsules.

Main study parameters/endpoints: The main study parameter is the number of aggressive incidents from baseline to endpoint (16 weeks post baseline), as measured using the Dutch version of the Modified Overt Aggression Scale (MOAS).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Clients who wish to participate enter a 2-week run-in phase during which they take 4 placebo capsules daily. After positive evaluation of this phase clients are randomised to either the active or control condition. Participants will then start the daily use of 4 supplement capsules or 4 placebo capsules, which continues for 16 weeks. At baseline and endpoint 2 questionnaires will be administered: the Intellectual Disability Quality of Life (IDQOL-16) and the Dutch Healthy Diet Food Frequency Questionnaire (DHD-FFQ). Small hair and faeces samples will be collected at baseline and 16 weeks. The data collection will take less than an hour per client and will take place at the location where the client resides. Aggression incidents will be registered by staff members using the MOAS. Also a staff member will fill in the Social Dysfunction Aggression Scale (SDAS) at baseline and endpoint, measuring observed levels of aggression and social dysfunction. The risks of participating in this study are minimal. The use of the Bonusan Multi Vital Forte Actief, or similar supplements has not been associated with any significant health risks and side effects. Potential benefits of participating in this study is an increase in quality of life through improved nutritional status, as well as a reduction of aggressive incidents. As this is a pragmatic trial in which the main objective is to determine whether the use of supplements has the potential to reduce the number of aggressive incidents among adolescents and young adults with an intellectual disability, it is imperative to include these subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 39 Years

Eligibility

Inclusion Criteria:

• intellectual disability

• living or day care in a health care organization

• age 12 till 39 years

• has a at least once a week an aggressive incident.

Exclusion Criteria:

• Pregnancy

• Breastfeeding

• people with Williams syndrome, hyperparathyroid or hemochromatosis.

• Current use of nutritional supplements and refusal to quit this use for the duration of the study.

• Failure to complete the two-week run-in phase.

• The use of the following medication: levothyroxine, methyldopa en levodopa

Related Conditions & MeSH terms

• Aggression
• Intellectual Disability

Intervention

Dietary Supplement:
• Multivitamin, mineral & n-3 FA
The 2 multi vitamin capsules with the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered
• Placebo
The placebo of the multi vitamin capsules and the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered

Locations

Country	Name	City	State
Netherlands	s Heeren Loo	Amersfoort
Netherlands	Amerpoort	Baarn
Netherlands	Syndion	Gorinchem
Netherlands	Gemiva-SVG	Gouda	Zuid Holland
Netherlands	Schakenbosch	Leidschendam	Zuid Holland
Netherlands	Amarant	Tilburg
Netherlands	Trajectum	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Gajos JM, Beaver KM. The effect of omega-3 fatty acids on aggression: A meta-analysis. Neurosci Biobehav Rev. 2016 Oct;69:147-58. doi: 10.1016/j.neubiorev.2016.07.017. Epub 2016 Jul 20. 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

Long SJ, Benton D. A double-blind trial of the effect of docosahexaenoic acid and vitamin and mineral supplementation on aggression, impulsivity, and stress. Hum Psychopharmacol. 2013 May;28(3):238-47. doi: 10.1002/hup.2313. Epub 2013 Apr 29. — View Citation

Raine A, Cheney RA, Ho R, Portnoy J, Liu J, Soyfer L, Hibbeln J, Richmond TS. Nutritional supplementation to reduce child aggression: a randomized, stratified, single-blind, factorial trial. J Child Psychol Psychiatry. 2016 Sep;57(9):1038-46. doi: 10.1111/jcpp.12565. Epub 2016 May 11. — 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

Tammam JD, Steinsaltz D, Bester DW, Semb-Andenaes T, Stein JF. A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin, mineral and n-3 fatty acid supplementation in typically developing adolescent schoolchildren. Br J Nutr. 2016 Jan 28;115(2):361-73. doi: 10.1017/S0007114515004390. Epub 2015 Nov 17. — 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
Primary	Aggression	The amount of aggressive behavior registered with the Modified Overt Aggression Scale (MOAS).This is a four item aggression scale which distinguishes verbal aggression, aggression to objects, self-aggression and physical aggression to others.	The aggression will be reported daily by the staff during a period of 18 weeks
Secondary	Aggression and anti-social behavior	Aggressive- and anti-social behavior measured with the SDAS-11. An eleven item aggression scale. The severity of each item can range from 1 to 5 on a Likert scale.	At baseline and in the 18th week
Secondary	Quality of Life IDQOL-16	Quality of life measured with the IDQOL-16.	At baseline and in the 18th week
Secondary	Cortisol status	The cortisol status measured with hair analyses.	At baseline and in the 18th week
Secondary	Microbiome	The micobiome measured with feces analysis.	At baseline and in the 18th week