MADDY 2.0: Innovative Clinical Trial on the use of multinutrients to treat youth with ADHD and emotional dysregulation

University of Lethbridge/University of Calgary

The goal of this project is to build research capacity in SPOR Innovative Clinical Trials by building on the results of a randomized clinical trial. The Micronutrients for ADHD in Youth (MADDY) Study was a multi-site trial testing the benefit of a multi-nutrient formula consisting of vitamins, minerals, amino acids, and antioxidants in children ages 6 to 12 years who were specifically recruited for ADHD and irritable mood symptoms. The results of the study demonstrated global benefit of multinutrients (54%) over placebo (18%) by blinded clinician rating, but not by parent-reported outcome. Micronutrients showed greater height growth and was well tolerated as well as having an excellent safety profile.

We are looking for patient partners to guide the next phase of an innovative clinical trial with the potential to generate high impact results from the next randomized clinical trial. For the next randomized clinical trial, we will identify characteristics of patients that are most likely to respond to treatments in the population that are consistent with precision/personalized medicine. As a patient partner, you will be involved in deciding key features for identifying the sample characteristics to include in the sample study, such as age (assigned dosage level), sex, race/ethnicity, parental health, severity of ADHD, duration of illness, etc. Patient partners will be integral to interpret analyses conducted for hypothesis-generation purposes.

Roles and responsibilities
We are looking for patient partners  who are youth with ADHD, and parents or caregivers of children with ADHD who are interested in non-pharmaceutical interventions for children with ADHD to join a CIHR grant application and to continue on as patient research partners should this project become funded. We are looking for patient partners to be active members of the patient-oriented research team involved in designing the next randomized clinical trial. Thus you will be asked for input to developing research questions pertinent to the patient perspective.
For the CIHR grant application opportunity, patient partners will be asked to attend online meetings (weekly or bi-weekly until July 12, 2023), provide input on drafts of the project proposal, provide insights, feedback and suggestion on the design and methods from a patient perspective, and provide a Canadian Common CV (CCV)in CIHR biosketch format. Support is available to complete the CCV.

Time commitment
The grant application phase is developing the proposal and the time frame is until July 19, 2023 (application deadline).
If the application is successful, then the timeframe to carry out the project is one year following the award of funds, and time commitment is negotiable. It is not currently know when the awarding of funds is scheduled to happen.

This is an online grant funding application opportunity. Collaborating on the grant application is a voluntary opportunity however if funding is received, an honorarium will be offered to patient partners who collaborate on team and proposal development for the next phase of the study.

Brenda Leung

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Land Acknowledgment

The Alberta SPOR SUPPORT Unit operates on and acknowledges the lands that are the traditional and ancestral territory of many peoples, presently subject to Treaties 6, 7, and 8. Namely: the Blackfoot Confederacy – Kainai, Piikani, and Siksika – the Cree, Dene, Saulteaux, Nakota Sioux, Stoney Nakoda, and the Tsuu T’ina Nation and the Métis People of Alberta. This includes the Métis Settlements and the Métis Nation of Alberta. We acknowledge the many First Nations, Métis and Inuit who have lived in and cared for these lands for generations. We make this acknowledgment as a reaffirmation of our shared commitment towards reconciliation, and as part of AbSPORU’s mandate towards fostering health system transformation.