NCT03252522

Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study

Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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-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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants	60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
DIETARY_SUPPLEMENT	Placebo	40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.

Timeline

• Start date: 2018-04-23
• Primary completion: 2020-07-10
• Completion: 2021-05-31
• First posted: 2017-08-17
• Last updated: 2023-02-08
• Results posted: 2022-02-09

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study