Impulsive BehaviorVANTASTICNCT03898336
Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity
A study testing broad-spectrum micronutrient in people with Impulsive Behavior, run by Radboud University Medical Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Impulsive Behavior
- What is being tested?
- broad-spectrum micronutrient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Central Institute of Mental Health
Mannheim, 68159
Alexander Haege, Dr., +49 621 1703 4541, alexander.haege@zi-mannheim.de
Ruth Berg, +49 621 1703 4541, ruth.berg@zi-mannheim.de
About this study
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.
Read more
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.
- Conditions
- Impulsive Behavior
- Being tested
- broad-spectrum micronutrient, placebo
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
broad-spectrum micronutrientOther
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)
placeboOther
daily intake of capsules
| Study group | Role | What they receive |
|---|---|---|
| broad-spectrum micronutrients | Experimental | 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) Receives: Other: broad-spectrum micronutrient |
| placebo | Placebo comparator | capsules containing placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks (end of placebo-controlled phase)
Secondary outcomes (8)
Change in Clinician rating of compulsivity
Children´s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS, Scahill et al., 1997)
Measured: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Change in the rating of irritability
Perceived Stress Scale (PSS-10, Taylor 2015)
Measured: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Change in sleep problems
Sleep problems (5-item questionnaire, self-rating of sleep problems)
Measured: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
change in motor activity (optional)
mHealth (movisens DataAnalyzer software)
Measured: at baseline and after 10 weeks of study participation
Change in ADHD symptom severity total score
Swanson, Nolan and Pelham Rating Scale (SNAP, Swanson et al. 2001)
Measured: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
change in rating of aggression
Retrospective Modified Overt Aggression Scale (R-MOAS, Blader et al. 2010)
Measured: every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
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
Measured: every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
change in treatment adherence
assessed by Attitudes Towards Treatment questionnaire; total score 0-108; better Outcome: lower score
Measured: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start18 Sep 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo controlled following open label phase
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim, University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Alexander Haege, Dr., Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898336
- Sponsor's protocol ID
- VANTASTIC STUDY
- Acronym
- VANTASTIC
- Status last verified
- Apr 2021
- First submitted
- 7 Feb 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat2beNICE Vitamins and Nutrients as Supplementation for Impulsivity, Irritability, and Compulsivity
- ClinicalTrials.gov ID
- NCT03898336
- Acronym / sponsor ID
- VANTASTIC / VANTASTIC STUDY
- Conditions
- Impulsive Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim, University Medical Center Groningen
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind placebo controlled following open label phase
| Arm | Type | Receives |
|---|---|---|
| broad-spectrum micronutrients | Experimental | Other: broad-spectrum micronutrientbroad-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) |
| placebo | Placebo comparator | Other: placebocapsules containing placebo |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| broad-spectrum micronutrientdaily 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) | Other | broad-spectrum micronutrients |
| placebodaily intake of capsules | Other | placebo |
Primary outcome
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
Time frame: 10 weeks (end of placebo-controlled phase)
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.
8 secondary outcomes
Change in Clinician rating of compulsivity
Time frame: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Change in the rating of irritability
Time frame: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Change in 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)
change in motor activity (optional)
Time frame: at baseline and after 10 weeks of study participation
Change in ADHD symptom severity total 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)
change in rating of aggression
Time frame: every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Rates of adverse events of the treatment groups in comparison to placebo group
Time frame: every 5 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
change in treatment adherence
Time frame: every 10 weeks over the whole study period of 20 weeks (10 weeks placebo-controlled phase followed by 10 weeks open label)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Haege, Dr. principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing broad-spectrum micronutrient in people with Impulsive Behavior, run by Radboud University Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Berg (+49 621 / 1703 ext. 4541, ruth.berg@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 10 weeks (end of placebo-controlled phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.