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

Last updated: May 6, 2025
Sponsor: SmartyPants Vitamins Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Brain Function

Treatment

Placebo

Kids Plus Multi & Omega

Clinical Study ID

NCT06807346
24SVCFS01
  • Ages 4-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females 4-17 years of age, inclusive

  2. Females of child-bearing potential must have a negative screening urine pregnancytest and agree to use a medically approved method of birth control for the durationof the study. All hormonal birth control must have been in use for a minimum ofthree months. Acceptable methods of birth control include:

  • Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

  • Double-barrier method

  • Intrauterine devices

  • Non-heterosexual lifestyle and agrees to use contraception if planning onchanging to heterosexual partner(s)

  • Vasectomy of partner at least 6 months prior to screening

  • Abstinence and agrees to use contraception if planning to become sexuallyactive during the study

  1. Enrolled in and currently attending school at baseline and for the duration of thestudy period

  2. Willing to complete evaluations, measurements, questionnaires and diaries duringeach clinic visit

  3. Agrees to avoid eating or moderate-vigorous exercise for one hour prior to clinicvisits

  4. Agrees to maintain current lifestyle habits (diet, physical activity, medications,supplements, and sleep) as much as possible throughout the study and avoid takingnew supplements

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

  6. 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 participatein the study

  7. Healthy as determined by medical history as assessed by Qualified Investigator (QI)

Exclusion

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study

  2. Allergy, sensitivity, or intolerance to the investigational product or placeboingredients

  3. Previous diagnosis or treatment of a significant neuropsychological condition and/orcognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stressdisorder, brain injury, neurodegenerative disease, infections, insomnia, depression,epileptic or other seizure-related disorders) that could interfere with studyparticipation as assessed by the QI

  4. Unable to communicate or cooperate due to language problems, learning disability,poor mental development, or impaired cerebral functions as assessed by the QI

  5. Previous diagnosis of Attention-deficit hyperactivity disorder (ADHD)

  6. Previous diagnosis of visual (including color blindness/weakness) or hearingimpairment that may impact task performance as assessed by the QI

  7. Currently experiencing major social/family stressors as confirmed by the child'sparent or legal guardian (s)

  8. History or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal condition whichaffects absorption, or pancreatic disorders, as assessed by the QI

  9. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy orradiation with a follow up that is negative. Volunteers with cancer in fullremission for more than five years after diagnosis are acceptable

  10. Individuals with an autoimmune disease or are immune compromised

  11. Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption

  12. Alcohol or drug abuse within the last 12 months

  13. Current use of prescribed and/or over-the-counter (OTC) medications, supplements,and/or consumption of food/drinks that may impact the efficacy of theinvestigational product (Sections 7.3.1 and 7.3.2)

  14. Employees/children of employees of study sponsor or research organization

  15. Participation in other clinical research studies 30 days prior to baseline, asassessed by the QI

  16. Parent or guardian who are unable to give informed consent

  17. Any other condition or lifestyle factor, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 06, 2025
Estimated Completion Date:
June 30, 2025

Study 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 56 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.

Connect with a study center

  • KGK Science Inc.

    London, Ontario N6B3L1
    Canada

    Active - Recruiting

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