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

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ClinicalTrials.gov Identifier: NCT03898336
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
Central Institute of Mental Health, Mannheim
University Medical Center Groningen
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Impulsivity is a cross-disorder symptom domain which affects a significant proportion of adolescents.

Predominately as part of attention deficit hyperactivity disorder (ADHD) but also as symptom domain without a diagnosis of ADHD, impulsivity causes 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 and compulsivity in children and adolescents between 10 and 18 years of age with a high level of impulsivity with or without a diagnosis of attention deficit hyperactivity disorder (ADHD).

The investigators intend to include 180 children and adolescents (n=110 in Germany) with a high level of impulsivity.

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.


Condition or disease Intervention/treatment Phase
Impulsive Behavior Other: broad-spectrum micronutrient Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind placebo controlled following open label phase
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eat2beNICE Vitamins and Nutrients as Supplementation Therapy for Impulsivity and Compulsivity
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Experimental: broad-spectrum micronutrients
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)
Other: broad-spectrum micronutrient
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)

Placebo Comparator: placebo
capsules containing placebo
Other: placebo
daily intake of capsules




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    Children´s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS, Scahill et al., 1997)

  2. 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) ]
    Perceived Stress Scale (PSS-10, Taylor 2015)

  3. 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) ]
    Sleep problems (5-item questionnaire, self-rating of sleep problems)

  4. change in motor activity (optional) [ Time Frame: at baseline and after 10 weeks of study participation ]
    mHealth (movisens DataAnalyzer software)

  5. 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) ]
    Swanson, Nolan and Pelham Rating Scale (SNAP, Swanson et al. 2001)

  6. 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) ]
    Retrospective Modified Overt Aggression Scale (R-MOAS, Blader et al. 2010)

  7. 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) ]
    Compare rates of adverse events of the treatment groups to placebo group to assess safety and tolerability

  8. 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) ]
    assessed by Questionnaire on Attitudes Towards Treatment questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 10;0 - 17; 6 years at initial inclusion
  • Subjects with a high level of impulsivity based on a CGI-S-score ≥ 4 and an Affective Reactivity Index (ARI) score ≥ 5 indicating a high level of multi-dimensional impulsivity
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898336


Contacts
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Contact: Ruth Berg +49 621 / 1703 ext 4541 ruth.berg@zi-mannheim.de

Sponsors and Collaborators
Radboud University
Central Institute of Mental Health, Mannheim
University Medical Center Groningen
Investigators
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Principal Investigator: Alexander Haege, Dr. Central Institute of Mental Health, Mannheim

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03898336     History of Changes
Other Study ID Numbers: VANTASTIC STUDY
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Impulsive Behavior
Vitamins
Calcifediol
Nutrients
Micronutrients
Trace Elements
Magnesium Oxide
Growth Substances
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Bone Density Conservation Agents