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Reducing Aggression Among People With an Intellectual Disability

NCT03212092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2021-03-09

No results posted yet for this study

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

Interventions

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

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Erik Giltay, MD, PHD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-02-01
Completion
2021-03-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212092 on ClinicalTrials.gov