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Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity (VANTASTIC)

Primary Purpose

Impulsive Behavior

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

broad-spectrum micronutrient

placebo

About this trial

This is an interventional treatment trial for Impulsive Behavior

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, aged 11;0 - 17; 6 years at initial inclusion
Subjects with a high level of impulsivity/ irritability based on a CGI-S-score ≥ 4 and a parent-rated Affective Reactivity Index (ARI) score ≥ 5 indicating a high level of multi-dimensional irritability
Subjects with or without a research diagnosis of attention deficit hyperactivity disorder (ADHD). ADHD has to be confirmed by structured diagnostic interview (ADHD section of Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS))
Deemed reliable and compliant with the protocol (including the ingestion of as many capsules as prescribed by the investigator)
Ability to comprehend and speak the native language of the country in which the assessments take place
Signed informed consent by parents or legal representative
Signed informed assent by child or adolescent (indicating that the subject is aware of the investigational nature and the core aspects of the study and the study is run in accordance with the ICH GCP guideline E6 (R2) (2016))

Exclusion Criteria:

Subject is being treated with a medication that might, in the opinion of the investigator, pose a safety risk for the subject when participating in this study
Intellectual disability (based on available IQ or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level)
Any known abnormality of mineral metabolism (e.g., Wilson's disease, haemochromatosis)
History of or present clinically relevant somatic or psychiatric acute or chronic disorder that, in the opinion of the investigator, might confound the results of tolerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient.
Subject has taken any kind of food supplement containing vitamins, minerals and/or trace elements within 30 days prior to entering the study
Subject has unstable treatment conditions (current changes in medication and/or psychotherapy) that might in the opinion of the investigator confound the results of the study with respect to impulsivity/irritability.
Subject has a documented allergy, hypersensitivity, or intolerance to any of the ingredients of the investigational product
Subject has taken another investigational product or taken part in a clinical study within 30 days prior to entering the study

Sites / Locations

Central Institute of Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

broad-spectrum micronutrients

placebo

Arm Description

broad-spectrum micronutrients description: capsules containing a blend of Vitamin B3 (NADH), Vitamin B6 (pyridoxal-5-phosphate), folic acid (5-MTHF), Vitamin B12 (methylcobalamin), Vitamin D3 (25-hydroxyvitamin D3), Magnesium (magnesium oxide), Zinc (zinc methionine), Iron (ferric phosphate), Selenium (selenomethionine), Phospholipids, L-carnitine (L-carnitine-L-tartrate)

capsules containing placebo

Outcomes

Primary Outcome Measures

response rate at end of placebo-controlled phase defined as CGI-I score with focus on impulsivity of 1 or 2 [=very much improved or much improved] plus reduction in Affective Reactivity Index (ARI) total score of at least 30% compared to baseline

The primary objective is to investigate the double-blind placebo controlled (10 weeks) effects of broad-spectrum micronutrients in highly impulsive children and adolescents (10-18 years; N=180 in total) with a high level of impulsivity with or without diagnosis of attention deficit hyperactivity disorder (ADHD). The primary outcome measure is the response rate at the end of the placebo-controlled phase. Response is defined as a Clinical Global Impression - Improvement score (CGI-I, Guy 1976; NIMH 1985) with a focus on impulsivity of 1 or 2 [=very much improved or much improved] plus a reduction in the Affective Reactivity Index (ARI, parent-rated, Stringaris et al. 2012) total score of at least 30% compared to baseline.

Secondary Outcome Measures

Change in Clinician rating of compulsivity

Children´s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS, Scahill et al., 1997)

Change in the rating of irritability

Perceived Stress Scale (PSS-10, Taylor 2015)

Change in sleep problems

Sleep problems (5-item questionnaire, self-rating of sleep problems)

change in motor activity (optional)

mHealth (movisens DataAnalyzer software)

Change in ADHD symptom severity total score

Swanson, Nolan and Pelham Rating Scale (SNAP, Swanson et al. 2001)

change in rating of aggression

Retrospective Modified Overt Aggression Scale (R-MOAS, Blader et al. 2010)

Rates of adverse events of the treatment groups in comparison to placebo group

Compare rates of adverse events of the treatment groups to placebo group to assess safety and tolerability

change in treatment adherence

assessed by Attitudes Towards Treatment questionnaire; total score 0-108; better Outcome: lower score

Full Information

NCT ID

NCT03898336

First Posted

February 7, 2019

Last Updated

April 15, 2021

Sponsor

Radboud University Medical Center

Collaborators

Central Institute of Mental Health, Mannheim, University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT03898336

Brief Title

Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity

Acronym

VANTASTIC

Official Title

Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 18, 2019 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

Collaborators

Central Institute of Mental Health, Mannheim, University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Impulsivity, irritability and compulsivity are cross-disorder symptom domains, which affect a significant proportion of adolescents. Predominately as part of attention deficit hyperactivity disorder (ADHD) but also as symptom domains without a diagnosis of ADHD, impulsivity and irritability cause serious burden. Furthermore, treatment options and their effects are limited. Previous studies with different study designs assessing micronutrients for the treatment of impulsivity / ADHD in children and adults have reported positive benefits as well as a very good tolerability. However, more research is required; in particular controlled studies with adolescents, cross-disorder approaches and studies investigating long-term effects are missing. The focus of this study is to investigate the effect of micronutrients on impulsivity, irritability and compulsivity in children and adolescents between 11 and 18 years of age with a high level of impulsivity and irritability with or without a diagnosis of attention deficit hyperactivity disorder (ADHD). The investigators intend to include 210 children and adolescents (n=110 in Germany) with a high level of impulsivity and irritability. The study is divided in two phases. An initial 10-week double blind, placebo-controlled treatment phase with broad-spectrum micronutrients is followed by a 10-week open-label treatment phase. The study assessments will be performed during five study visits and a follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impulsive Behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

double-blind placebo controlled following open label phase

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

broad-spectrum micronutrients

Arm Type

Experimental

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

capsules containing placebo

Intervention Type

Other

Intervention Name(s)

broad-spectrum micronutrient

Intervention Description

daily intake of capsules containing a blend of Vitamin B3 (NADH), Vitamin B6 (pyridoxal-5-phosphate), folic acid (5-MTHF), Vitamin B12 (methylcobalamin), Vitamin D3 (25-hydroxyvitamin D3), Magnesium (magnesium oxide), Zinc (zinc methionine), Iron (ferric phosphate), Selenium (selenomethionine), Phospholipids, L-carnitine (L-carnitine-L-tartrate)

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

daily intake of capsules

Primary Outcome Measure Information:

Title

Description

Time Frame

10 weeks (end of placebo-controlled phase)

Secondary Outcome Measure Information:

Title

Change in Clinician rating of compulsivity

Description

Children´s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS, Scahill et al., 1997)

Time Frame

every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

Change in the rating of irritability

Description

Perceived Stress Scale (PSS-10, Taylor 2015)

Time Frame

every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

Change in sleep problems

Description

Sleep problems (5-item questionnaire, self-rating of sleep problems)

Time Frame

every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

change in motor activity (optional)

Description

mHealth (movisens DataAnalyzer software)

Time Frame

at baseline and after 10 weeks of study participation

Title

Change in ADHD symptom severity total score

Description

Swanson, Nolan and Pelham Rating Scale (SNAP, Swanson et al. 2001)

Time Frame

every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

change in rating of aggression

Description

Retrospective Modified Overt Aggression Scale (R-MOAS, Blader et al. 2010)

Time Frame

every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

Rates of adverse events of the treatment groups in comparison to placebo group

Description

Compare rates of adverse events of the treatment groups to placebo group to assess safety and tolerability

Time Frame

every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

Title

change in treatment adherence

Description

assessed by Attitudes Towards Treatment questionnaire; total score 0-108; better Outcome: lower score

Time Frame

every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, aged 11;0 - 17; 6 years at initial inclusion Subjects with a high level of impulsivity/ irritability based on a CGI-S-score ≥ 4 and a parent-rated Affective Reactivity Index (ARI) score ≥ 5 indicating a high level of multi-dimensional irritability Subjects with or without a research diagnosis of attention deficit hyperactivity disorder (ADHD). ADHD has to be confirmed by structured diagnostic interview (ADHD section of Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)) Deemed reliable and compliant with the protocol (including the ingestion of as many capsules as prescribed by the investigator) Ability to comprehend and speak the native language of the country in which the assessments take place Signed informed consent by parents or legal representative Signed informed assent by child or adolescent (indicating that the subject is aware of the investigational nature and the core aspects of the study and the study is run in accordance with the ICH GCP guideline E6 (R2) (2016)) Exclusion Criteria: Subject is being treated with a medication that might, in the opinion of the investigator, pose a safety risk for the subject when participating in this study Intellectual disability (based on available IQ or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level) Any known abnormality of mineral metabolism (e.g., Wilson's disease, haemochromatosis) History of or present clinically relevant somatic or psychiatric acute or chronic disorder that, in the opinion of the investigator, might confound the results of tolerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient. Subject has taken any kind of food supplement containing vitamins, minerals and/or trace elements within 30 days prior to entering the study Subject has unstable treatment conditions (current changes in medication and/or psychotherapy) that might in the opinion of the investigator confound the results of the study with respect to impulsivity/irritability. Subject has a documented allergy, hypersensitivity, or intolerance to any of the ingredients of the investigational product Subject has taken another investigational product or taken part in a clinical study within 30 days prior to entering the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruth Berg

Phone

+49 621 / 1703

Ext

4541

ruth.berg@zi-mannheim.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Haege, Dr.

Organizational Affiliation

Central Institute of Mental Health, Mannheim

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Institute of Mental Health

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Haege, Dr.

Phone

+49 621 1703 4541

alexander.haege@zi-mannheim.de

First Name & Middle Initial & Last Name & Degree

Ruth Berg

Phone

+49 621 1703 4541

ruth.berg@zi-mannheim.de

First Name & Middle Initial & Last Name & Degree

Alexander Haege, Dr.

12. IPD Sharing Statement

Learn more about this trial

Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity

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