Kids Plus Multi & Omega for Cognition

Overseen By Erin Lewis, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: SmartyPants Vitamins Inc.

Must not be taking: Cannabinoids, Tobacco, Alcohol, others

Disqualifiers: Neuropsychological conditions, ADHD, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the efficacy of Kids Plus Multi \& Omega dietary supplement on cognitive function in children after 56 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.

Do I have to stop taking my current medications for the trial?

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible throughout the study. However, if you are taking medications or supplements that may impact the efficacy of the investigational product, you may not be eligible to participate.

How does the Kids Plus Multi & Omega treatment differ from other treatments for cognitive improvement in children?

Kids Plus Multi & Omega is unique because it combines omega-3 fatty acids, which are essential for brain function, with other nutrients in a single treatment. This combination may offer a more comprehensive approach to supporting cognitive development compared to treatments that focus solely on omega-3 supplementation. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for children who can safely consume dietary supplements and are able to complete cognitive tests. Specific eligibility details aren't provided, but typically participants must be in good health with no conditions that could interfere with the supplement or test results.

Inclusion Criteria

Enrolled in and currently attending school at baseline and for the duration of the study period

A care provider who can reliably bring the participant to all study visits; the participant's primary caregiver must be willing and able to complete the questionnaires as needed for all visits

The child and the child's parent(s) or legal guardian(s) have given voluntary, written, informed assent and consent, respectively, for their child to participate in the study

Exclusion Criteria

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Individuals with an autoimmune disease or are immune compromised

Alcohol or drug abuse within the last 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume Kids Plus Multi & Omega or placebo and complete cognitive assessment tests

8 weeks

Regular visits for cognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Kids Plus Multi & Omega

Trial Overview The study is testing whether Kids Plus Multi & Omega improves brain functions like memory and attention in kids compared to a placebo. Over 56 days, children will take either the supplement or placebo and undergo cognitive assessments to measure any changes.

Participant Groups

Group I: Kids Plus Multi & Omegas Experimental Treatment 1 Intervention

Kids Plus Multi \& Omega is a dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids.

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

SmartyPants Vitamins Inc.

Lead Sponsor

Trials

1

Recruited

120+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

The Integrated Childhood Ocular Nutrition Study will investigate the effects of lutein and zeaxanthin supplementation on cognitive abilities and macular carotenoids in 288 preadolescent children over a 9-month period.

The study aims to determine if L + Z supplementation can enhance memory, attentional control, and academic performance, with the hypothesis that improvements will be linked to increased macular pigment density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Cannavale, CN., Keye, SA., Rosok, L., et al.[2023]

In a study involving 409 children aged 3-13 years, supplementation with fish oil containing omega-3 fatty acids led to significant improvements in non-verbal cognitive development, as measured by the Draw-A-Person test, particularly among Indigenous children aged 7-12.

While the fish oil treatment showed benefits in cognitive development, there were no significant effects on reading or spelling skills, suggesting that omega-3 supplementation may specifically enhance certain cognitive functions rather than overall academic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of fish oil supplementation on learning and behaviour of children from Australian Indigenous remote community schools: a randomised controlled trial. Parletta, N., Cooper, P., Gent, DN., et al.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Omega-3 Supplementation on Self-Regulation in Typically Developing Preschool-Aged Children: Results of the Omega Kid Pilot Study-A Randomised, Double-Blind, Placebo-Controlled Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation on Cognition in Children and Adolescents: A Systematic Literature Review with a Focus on n-3 LCPUFA Blood Values and Dose of DHA and EPA. [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effects of fish oil supplementation on learning and behaviour of children from Australian Indigenous remote community schools: a randomised controlled trial. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical significance of neuropsychological improvement after supplementation with omega-3 in 8-12 years old malnourished Mexican children: a randomized, double-blind, placebo and treatment clinical trial. [2014]