Kids Plus Multi & Omega for Cognition

Overseen By Erin Lewis, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SmartyPants Vitamins Inc.

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

Disqualifiers: Neuropsychological conditions, ADHD, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Kids Plus Multi & Omega dietary supplement can improve cognitive functions in children. Participants will take either the supplement or a placebo (a harmless pill with no active ingredients) and complete various cognitive tests over 49 days. The trial seeks healthy, school-aged children who attend school and can follow study guidelines. Children with significant neuropsychological conditions or on certain medications are not eligible. As an unphased trial, this study provides a unique opportunity for children to contribute to research that could enhance cognitive health.

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.

Is there any evidence suggesting that Kids Plus Multi & Omega is safe for children?

Research has shown that omega-3 fatty acids, a key component of Kids Plus Multi & Omega, are generally safe and can benefit brain health. Studies suggest that omega-3 supplements may aid brain development, particularly in children. These supplements are recommended throughout life due to their benefits.

Multivitamins, also included in Kids Plus Multi & Omega, support children's growth and development. They typically contain essential vitamins and minerals like vitamins C, D3, and B12, which are crucial for overall health.

Although specific safety data for Kids Plus Multi & Omega is not available, the ingredients are well-known and generally safe for children. However, like any supplement, there is a small chance of mild side effects or allergies. Consulting a healthcare provider before starting any new supplement is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cognitive enhancement, which often include pharmaceuticals or behavioral therapies, Kids Plus Multi & Omega is a dietary supplement that combines a mix of vitamins, minerals, and omega-3 fatty acids. Researchers are excited about this treatment because it offers a natural approach that could support brain health without the side effects associated with medications. The inclusion of omega-3 fatty acids is particularly noteworthy, as these are essential fats that have been linked to improved brain function and development. This makes Kids Plus Multi & Omega a promising option for enhancing cognition in children in a safe and holistic way.

What evidence suggests that Kids Plus Multi & Omega might be an effective treatment for cognitive function in children?

Research has shown that omega-3 fatty acids, found in fish oil, can improve attention and thinking skills in children. One study with 409 children demonstrated noticeable improvements in non-verbal skills after taking omega-3 supplements. Additionally, a review found that omega-3s positively affect brain development, especially in young children. Although evidence about overall brain benefits is limited, these findings suggest that the Kids Plus Multi & Omega supplement, which contains omega-3s, might enhance brain function in children. Participants in this trial will receive either the Kids Plus Multi & Omega supplement or a placebo to evaluate its effectiveness. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-2-cognition-3-2025-f4f4c

Kids Plus Multi & Omega for Cognition · Info for Participants 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10498982/

A Systematic Review of Omega-3 Fatty Acid Consumption and ... In this review we summaries the finding on the effect of omega-3 supplementation on cognitive development across three neurodevelopmental periods: (1) in-utero, ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06807346/evaluating-the-efficacy-of-the-study-product-on-overall-cognitive-function-in-children

Evaluating the Efficacy of the Study Product on Overall ... 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 ...

4. mdpi.com mdpi.com/2304-8158/11/17/2595

Effectiveness of Fish Oil-DHA Supplementation for ... These findings indicate that fish oil intake leads to a consistent improvement in attention and cognitive processing ability.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622004114

Omega-3 Fatty Acid Dietary Supplements Consumed ... Limited evidence suggests that omega-3 fatty acid supplementation during pregnancy may result in favorable cognitive development in the child.

6. smartypantsvitamins.com smartypantsvitamins.com/products/kids-multi-and-omegas?srsltid=AfmBOoqohJHLcoxUltG8VtM2kMPmUJwb25vuVQ4sdY5N9z6z49DGx_W5

Kids Plus Multi & Omegas Multivitamin specifically-formulated to support kids growth and development with 16 daily nutrients including vitamins C, D3, B12, A, K1, and folate, as well ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05191823?term=AREA%5BInterventionSearch%5D(%22Arachidonic%20Acid%22)&rank=1

NCT05191823 | Omega Tots Long Term Follow-up The general cognitive ability score has a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best ...

8. amazon.com amazon.com/Best-Nest-Wellness-Liquid-Multivitamin/dp/B072J513XH

Best Nest Wellness Kids Multi Plus - Brain Health Support ... Daily Multivitamin for Kids: Our kids liquid multivitamin supports brain and immune health for growing brains and bodies; Active Methylated Vitamins: ...