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

Launched by SMARTYPANTS VITAMINS INC. · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a dietary supplement called Kids Plus Multi & Omega might help improve cognitive function, which refers to how well children think, learn, and remember things. Over a period of 56 days, children who participate will either take the supplement or a placebo (a harmless substance with no active ingredients) and then complete various tests to see if there are any differences in their cognitive abilities. The trial aims to find out if Kids Plus Multi & Omega really makes a difference compared to the placebo.

To be eligible for this study, children aged 4 to 17 years old can participate, as long as they are healthy and currently attending school. Both boys and girls can join, but there are some important requirements, like if a girl can become pregnant, she must use birth control during the study. Participants will need to complete tests and questionnaires during clinic visits, and their caregivers must help by bringing them to appointments and answering questions. The trial is not currently recruiting participants, but it's a great opportunity to contribute to research that could help improve children's cognitive health!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females 4-17 years of age, inclusive
• 2. 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
• • 3. Enrolled in and currently attending school at baseline and for the duration of the study period
• • 4. Willing to complete evaluations, measurements, questionnaires and diaries during each clinic visit
• • 5. Agrees to avoid eating or moderate-vigorous exercise for one hour prior to clinic visits
• • 6. 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
• • 7. 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
• • 8. 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
• • 9. Healthy as determined by medical history as assessed by Qualified Investigator (QI)
• Exclusion Criteria:
• • 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• • 2. Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
• • 3. 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
• • 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 hearing impairment that may impact task performance as assessed by the QI
• • 7. Currently experiencing major social/family stressors as confirmed by the child's parent or legal guardian (s)
• • 8. 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
• • 9. 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
• • 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 the investigational 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, as assessed 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, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant