Status:
COMPLETED
Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Ohio State University
University of Lethbridge
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
PHASE2
Brief Summary
This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.
Detailed Description
This study examines a broad spectrum micronutrient treatment for children with ADHD. The goal is to broaden the scope of evidence-based treatments, and to address the public desire for non-pharmacolog...
Eligibility Criteria
Inclusion
- Age inclusive of and between 6 and 12 years at the time of enrollment.
- Verbally willing to swallowing a maximum of 9-12 capsules/day with food, attend all study appointments and complete questionnaires.
- Meet criteria for ADHD as assessed by the clinical cut-off (6+ questions scored as 2's or 3's, "often," or "very often") on the Category A: ADHD questions from on the Child \& Adolescent Symptom Inventory-5 (CASI-5) with at least several symptoms present in more than one setting, based on the Diagnostic and Statistical Manual (DSM) 5 symptom criteria, including significant impairment in functioning socially and/or academically.
- Demonstrate at least one symptom of irritability or anger as assessed by a score of 2 or 3 on one question from Category B or Rz from the CASI-5.
- Be medication-free, or washout with medical supervision to be provided by the child's pediatrician or primary care physician, reliant on the parent/guardian to work with that physician, for at least two weeks prior to in-person study assessment. Washout will be recorded as occurring on the date reported by the parent/guardian, with a faxed copy of the progress note, visit summary or signed letter from participant's doctor.
Exclusion
- Neurological disorder involving brain or other central function (e.g., history of or suspected intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition and responses to category M on the CASI-5 subscale.
- Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II.
- Known allergy to any ingredients of the intervention.
- Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis).
- Taking any other medication with primarily central nervous system activity, including stimulants, within the last two weeks prior to in-person assessment; participants must be off these medications for a minimum of two weeks prior to the screening.
- Severe separation anxiety that would preclude separating from parent/guardian to answer study questionnaires.
- Any disability that would interfere with participant answering questions verbally.
- Non-English speaking.
- Pregnancy or sexually active at baseline. Exclusion criteria 1-6 and 9, will be based on parent/guardian self-report of child's condition. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participant may be reviewed in-person by a study physician in the case of any concerns about participation.
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03252522
Start Date
April 23 2018
End Date
May 31 2021
Last Update
February 8 2023
Active Locations (3)
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1
The Ohio State University
Columbus, Ohio, United States, 43210
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
University of Lethbridge
Lethbridge, Alberta, Canada, AB T1K 6T5