Vitamins and Nutrients as Supplementation for Irritability (VANTASTIC Study) - A Double-blind Randomized Placebo-Controlled Trial

Completed

Conditions: prikkelbaarheid
irritabilty

Registration Number: NL-OMON49773

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

• Aged 11;0-17; 6 years
• Presence of a high level of irritability based on an Affective Reactivity
Index (ARI) score >= 5 according to parent report.
• Presence or absence of ADHD in a ratio of 2:1. Those without ADHD may have
any behavioral or emotional disorder (such as ODD, CD, and any affective
disorder). All types of comorbidities are allowed.

Exclusion Criteria

• Subject is in the opinion of the investigator not able to comply with study
proce-dures, such as swallowing capsules; or if participation in this study may
pose a safety risk.
• Intellectual disability (based on available IQ below 70 or the clinical
opinion of the investigator, taking into account relevant psychosocial
information, e.g. educa-tional level; or as confirmed by obtained IQ during the
optional cognitive meas-urements)
• Any known abnormality of mineral metabolism (e.g., Wilson*s disease,
haemo-chromatosis)
• Subject has a documented allergy, hypersensitivity, or intolerance to any of
the in-gredients of the investigational product
• Subjects with diabetes mellitus (type 1 or 2) cannot take part in the
microbiome measurements.
• Subject has taken another nutritional supplement product or taken part in a
clinical study within 30 days prior to entering the study
• Subject is receiving ongoing psychosocial treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the response rate (dichotomous score) at the end of the<br /><br>placebo-controlled phase. Response is defined as a clinical global impression<br /><br>scale of improvement (CGI-I) score with a focus on irritability of 1 or 2 [=<br /><br>very much improved or much improved] plus a reduction in the Affective<br /><br>Reactivity Index (ARI, parent-rated) total score of at least 30% compared to<br /><br>baseline.<br /><br><br /><br>• Clinical Global Impression - Severity (CGI-S and CGI-I): clinical global<br /><br>assessment by clinician (focused on irritability)<br /><br>• Affective Reactivity Index (ARI, 1-week version): parent rating of<br /><br>irritability </p><br>

Secondary Outcome Measures