Reducing Aggression Among People With an Intellectual Disability

NCT03212092 | Completed DMC

• 1 other identifier: NL60839.058.17
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Aggression; Intellectual Disability

Keywords

Aggression; aggressive behavior; nutritional supplements; dietary supplements; vitamin, mineral; omega-3; n-3 fatty acids; intellectual disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Aggression and anti-social behavior

  At baseline and in the 18th week

• Quality of Life IDQOL-16

  At baseline and in the 18th week

• Cortisol status

  At baseline and in the 18th week

• Microbiome

  At baseline and in the 18th week

Study Arms (2)

Multivitamin, mineral & n-3 FA

EXPERIMENTAL

The daily supplementation of multivitamin- and mineral in 2 capsules and n-3 fatty acids in 2 softgel capsules.

Dietary Supplement: Multivitamin, mineral & n-3 FA

Placebo

PLACEBO COMPARATOR

The placebo consists of daily supplementation of 2 capsules with rice bran extract, hypromellose and 1.6 mg riboflavin. And 2 softgel capsules with a vegetable oil.

Dietary Supplement: Placebo

Interventions

Multivitamin, mineral & n-3 FA DIETARY_SUPPLEMENT

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

Multivitamin, mineral & n-3 FA

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 12 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (7)

Trajectum

Zwolle, Overijssel, 8017 KZ, Netherlands

Location

Gemiva-SVG

Gouda, South Holland, 2803 HG, Netherlands

Location

Schakenbosch

Leidschendam, South Holland, 2263 SZ, Netherlands

Location

s Heeren Loo

Amersfoort, Netherlands

Location

Amerpoort

Baarn, Netherlands

Location

Syndion

Gorinchem, Netherlands

Location

Amarant

Tilburg, Netherlands

Location

Related Publications (8)

• 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. doi: 10.1089/acm.2000.6.7.

  PMID: 10706231 BACKGROUND

• 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.

  PMID: 12091259 BACKGROUND

• 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.

  PMID: 20014286 BACKGROUND

• 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.

  PMID: 23625531 BACKGROUND

• 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.

  PMID: 27166583 BACKGROUND

• 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.

  PMID: 26573368 BACKGROUND

• 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.

  PMID: 27450580 BACKGROUND

• 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.

  PMID: 35040231 DERIVED

MeSH Terms

Conditions

Aggression; Intellectual Disability; Calcinosis

Interventions

Geritol; Minerals

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Erik Giltay, MD, PHD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo with the appearance as the dietary supplements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: The study is a pragmatic multicenter randomized double-blind placebo-controlled intervention trial with an intervention period of 4 months. Since the washout period of several components of dietary supplements is unknown we chose a parallel design.

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 11, 2017
• Study Start: January 15, 2018
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)