CognitionNCT06807346
Evaluating the Efficacy of the Study Product on Overall Cognitive Function in Children
A study testing Kids Plus Multi & Omega in people with Cognition, run by SmartyPants Vitamins Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Kids Plus Multi & Omega
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2025to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
- Parent or guardian who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled Trial Evaluating the Efficacy of the Study Product on Overall Cognitive Function in Children
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.
Read the 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
- Being tested
- Kids Plus Multi & Omega, Placebo
- Keywords
- Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kids Plus Multi & OmegaDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Kids Plus Multi & Omegas | Experimental | Kids Plus Multi \& Omega is a dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids. Receives: Dietary Supplement: Kids Plus Multi & Omega |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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) as assessed by the NIH Toolbox Cognition tests from baseline at Day 28 between Kids Plus Multi and Omega and placebo
Measured: 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
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) as assessed by the NIH Toolbox Cognition tests from baseline at Day 49 between Kids Plus Multi and Omega and placebo
Measured: Day 0 (baseline) to 49
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
The difference in change in quality of life as assessed by the KINDL-R questionnaire between Kids Plus Multi and Omega and placebo from baseline at Day 28.
Measured: Day 0 (baseline) to 28
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
The difference in change in quality of life as assessed by the KINDL-R questionnaire between Kids Plus Multi and Omega and placebo from baseline at Day 49
Measured: Day 0 (baseline) to 49
The difference in change in stress between Kids Plus Multi and Omega and placebo
The difference in change in stress as assessed by Perceived Stress Scale for Children (PSS-C) between Kids Plus Multi and Omega and placebo from baseline at Day 28. The PSS-C has a scale range from 0-39 with higher scores indicating higher stress levels.
Measured: Day 0 (baseline) to 28
The difference in change in stress between Kids Plus Multi and Omega and placebo
The difference in change in stress as assessed by Perceived Stress Scale for Children (PSS-C) between Kids Plus Multi and Omega and placebo from baseline at Day 49. The PSS-C has a scale range from 0-39 with higher scores indicating higher stress levels.
Measured: Day 0 (baseline) to 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start6 May 2025
- Primary completion30 Jun 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- SmartyPants Vitamins Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807346
- Sponsor's protocol ID
- 24SVCFS01
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled Trial Evaluating the Efficacy of the Study Product on Overall Cognitive Function in Children
- ClinicalTrials.gov ID
- NCT06807346
- Acronym / sponsor ID
- 24SVCFS01
- Conditions
- Cognition
- Keywords
- Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SmartyPants Vitamins Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kids Plus Multi & Omegas | Experimental | Dietary Supplement: Kids Plus Multi & OmegaKids Plus Multi \& Omega is a dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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:
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kids Plus Multi & OmegaParticipants 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 | Kids Plus Multi & Omegas |
| PlaceboParticipants 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. | Dietary supplement | Placebo |
Primary outcome
The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 28
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
The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 49
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
6 secondary outcomes
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
Time frame: 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
Time frame: Day 0 (baseline) to 49
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 28
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 49
The difference in change in stress between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 28
The difference in change in stress between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kids Plus Multi & Omega in people with Cognition, run by SmartyPants Vitamins Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo (time frame: Day 0 (baseline) to 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.