Micronutrients for ADHD in Youth (MADDY) Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- "Attention Deficit Hyperactivity Disorder"
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Placebo-controlled; randomization created by statistician, all involved in the study and assessment are blindedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 12 years
- Gender
- Both males and females
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-pharmacological treatment options. This study will use a randomized controlled trial design, comparing micronut...
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-pharmacological treatment options. This study will use a randomized controlled trial design, comparing micronutrients with placebo in 135 children, ages 6-12, with ADHD plus irritability or anger based on parent-report of symptoms. The study will also collect biological samples (saliva, stool, urine, hair, and blood) from the children to examine physiological mechanisms of micronutrient effects. If the micronutrient treatment successfully diminishes symptoms, the clinical implication is to offer this as a legitimate non-pharmacological alternative to stimulant medication.
Tracking Information
- NCT #
- NCT03252522
- Collaborators
- Ohio State University
- University of Lethbridge
- Investigators
- Principal Investigator: Jeanette Johnstone Oregon Health and Science University
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