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

NCT06807346 | Completed

• 1 other identifier: 24SVCFS01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognition

Keywords

Cognition

Outcome Measures

Primary Outcomes (2)

• The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo

  The difference in change in individual cognitive domains as assessed by the NIH Toolbox Cognition tests from baseline at Day 28 between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 28

• The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo

  The difference in change in individual cognitive domains as assessed by the NIH Toolbox Cognition tests from baseline at Day 49 between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 49

Secondary Outcomes (6)

• The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 28

• The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 49

• The difference in change in quality of life between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 28

• The difference in change in quality of life between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 49

• The difference in change in stress between Kids Plus Multi and Omega and placebo

  Day 0 (baseline) to 28

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  Day 0 (baseline) to 49

• Clinically relevant changes in blood pressure (BP) after supplementation

  Day 0 (baseline) to 49

• Clinically relevant changes in heart rate (HR) after supplementation

  Day 0 (baseline) to 49

Study Arms (2)

Kids Plus Multi & Omegas

EXPERIMENTAL

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

Dietary Supplement: Kids Plus Multi & Omega

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Kids Plus Multi & Omega DIETARY_SUPPLEMENT

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.

Kids Plus Multi & Omegas

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males and females 4-17 years of age, inclusive
• Females of child-bearing potential must have a negative screening urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning to become sexually active during the study
• Enrolled in and currently attending school at baseline and for the duration of the study period
• Willing to complete evaluations, measurements, questionnaires and diaries during each clinic visit
• Agrees to avoid eating or moderate-vigorous exercise for one hour prior to clinic visits
• Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study and avoid taking new supplements
• 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
• Healthy as determined by medical history as assessed by Qualified Investigator (QI)

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
• Previous diagnosis or treatment of a significant neuropsychological condition and/or cognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
• Unable to communicate or cooperate due to language problems, learning disability, poor mental development, or impaired cerebral functions as assessed by the QI
• Previous diagnosis of Attention-deficit hyperactivity disorder (ADHD)
• Previous diagnosis of visual (including color blindness/weakness) or hearing impairment that may impact task performance as assessed by the QI
• Currently experiencing major social/family stressors as confirmed by the child's parent or legal guardian (s)
• History or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal condition which affects absorption, or pancreatic disorders, as assessed by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised
• Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption
• Alcohol or drug abuse within the last 12 months
• Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
• Employees/children of employees of study sponsor or research organization
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI

Sponsors & Collaborators

• SmartyPants Vitamins Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: May 6, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 7, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)