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

NCT ID: NCT03898336

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2022-09-30

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.

Conditions

Impulsive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

broad-spectrum micronutrient

Intervention Type: OTHER

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

capsules containing placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

daily intake of capsules

Interventions

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)

Intervention Type: OTHER

placebo

daily intake of capsules

Intervention Type: OTHER

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Haege, Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Locations

Central Institute of Mental Health

Mannheim, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ruth Berg

Role: CONTACT

ruth.berg@zi-mannheim.de

+49 621 / 1703 ext. 4541

Facility Contacts

Alexander Haege, Dr.

Role: primary

alexander.haege@zi-mannheim.de

+49 621 1703 4541

Ruth Berg

Role: backup

ruth.berg@zi-mannheim.de

+49 621 1703 4541

Other Identifiers

VANTASTIC STUDY

Identifier Type: -

Identifier Source: org_study_id