NCT06807346

Evaluating the Efficacy of the Study Product on Overall Cognitive Function in Children

A Randomized, Triple-blind, Placebo-controlled Trial Evaluating the Efficacy of the Study Product on Overall Cognitive Function in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: SmartyPants Vitamins Inc. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of Kids Plus Multi \& Omega dietary supplement on cognitive function in children after 49 days of supplementation. The main question it aims to answer is: Is there a difference in change in individual cognitive domains between Kids Plus Multi \& Omega and placebo? Participants will be asked to consume Kids Plus Multi \& Omega or placebo and complete various cognitive assessment tests throughout the duration of the study.

Detailed description

The investigational product, Kids Plus Multi \& Omega dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids. Emerging evidence reports the positive effects of micronutrient supplementation on cognitive performance among school-aged children. However, there is still limited evidence on the efficacy of multiple micronutrient supplementation on other aspects of cognitive function in children. Therefore, the objective of this randomized, triple-blind placebo-controlled clinical trial is to evaluate the efficacy of Kids Plus Multi \& Omega dietary supplement on cognitive function in children after 49 days of supplementation. Overall cognitive function as well as cognitive domains related to focus, memory, learning and cognitive flexibility will be assessed using the National Institutes of Health (NIH) Toolbox Cognition Battery.

Conditions

• Cognition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kids Plus Multi & Omega	Participants will be instructed to take two gummies of Kids Plus Multi and Omegas with or without food once daily for the duration of the study starting on Day 1 with a recommendation to consume in the morning for consistency.
DIETARY_SUPPLEMENT	Placebo	Participants will be instructed to take two gummies of placebo with or without food once daily for the duration of the study starting on Day 1 with a recommendation to consume in the morning for consistency.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-06-30
• Completion: 2025-07-07
• First posted: 2025-02-04
• Last updated: 2025-09-11

Locations

1 site across 1 country: Canada