Evidence map›Paper›PMID 35040231›Full record

Trial reportJournal of evaluation in clinical practice2022

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour.

Nienke J de Bles, David A A Gast, Abe J C van der Slot, Robert Didden, Albert M van Hemert, Nathaly Rius-Ottenheim, Erik J Giltay

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of evaluation in clinical practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02498106 nacompletednot on this map

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

TypeinterventionalSponsorLeiden University Medical CenterRan2015 to 2019Enrolled176ConditionsPsychiatric HospitalizationArmsOrthica Soft Multi Mini and Orthica Fish EPA Mini
NCT03212092 nacompletednot on this map

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

TypeinterventionalSponsorLeiden University Medical CenterRan2018 to 2021Enrolled137ConditionsAggression, Intellectual DisabilityArmsMultivitamin, mineral & n-3 FA, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Nutritional Criminology: Why the Emerging Research on Ultra-Processed Food Matters to Health and Justice.International journal of environmental research and public health · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Nienke J de BlesDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0001-6782-1629
David A A GastDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-9651-246X
Abe J C van der SlotDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-1985-5872
Robert DiddenBehavioural Science Institute, Radboud University, Nijmegen, The Netherlands.ORCID 0000-0001-5009-4269
Albert M van HemertDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0003-3421-355X
Nathaly Rius-OttenheimDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-0721-7152
Erik J GiltayDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0001-8874-2292
Leiden University Medical Center · NLRadboud University Nijmegen · NL

Funding

Innovatiefonds Zorgverzekeraars 3326ZonMw 836031016
6 · The paper itself

Abstract

backgroundSetting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs. APPROACH: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.

conclusionsBy sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register (RCT A: NCT02498106; RCT B: NCT03212092).

Indexed as

AggressionIntellectual DisabilityHumansaggressionlessons learnedmultisitenutritional supplementstrial

Identifiers

PMID35040231
PMCPMC9543803
OpenAlexW4206562190

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.