Welcome to the SmartyPants Kids Plus & Omega Supplement Study. To move forward in this study you are required to watch the ICF (Informed Consent form) video and read through the ICF attached before attending your first screening visit. If you have any questions in regards to this ICF that is not answered in the FAQ section below or you would like further explanation, please come with your questions ready to your assigned appointment or email the clinic staff at clinic@kgkscience.com.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the Smarty Pants Study.
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the parent/guardian and the child if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions. This video is meant for parents, legal guardians and the child to watch together. Some of the words we use in this video are directed more toward the parents/guardians, but that doesn’t mean the information is also not important to the child.
SmartyPants introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through both the ICF form and the ASSENT form (if your child is 7-13), as you will be required to sign them at your initial screening visit should you qualify for the study. Please do not sign them in advance as they must be signed at the visit after the study staff are assured all your questions have been answered.
ICF form (4-17yrs) - Please Review Here
ASSENT Form (7-14yrs)- please review Here
3. Frequently Asked Questions
What is the Purpose of this Clinical Trial?
- This clinical trial will explore if the investigational product Kids Plus Multi & Omega Dietary supplement. Kids Plus Multi & Omega dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids. Research suggests that taking omega-3 supplements can improve focus, memory, communication, and decision-making skills.
- Purpose of the study is to evaluate the efficacy of the study product on overall cognitive function in children
What is the study product? What is in it?
- If you are enrolled in the study, you will receive either the investigational product or the placebo.
- The investigational product contains:
Active Ingredients | Quantity per day (2 gummies) |
Vitamin A (retinyl palmitate) | 180 mcg |
Vitamin C (ascorbic acid) | 45 mg |
Vitamin D (cholecalciferol) | 20 mcg (800 IU) |
Vitamin E (d-alpha-tocopherol from sunflower oil) | 6.6 mg |
Vitamin K (phylloquinone) | 20 mcg |
Thiamin (thiamin mononitrate) | 0.1 mg |
Riboflavin | 0.16 mg |
Vitamin B6 (pyridoxine HCL) | 1 mg |
Folate (L-methylfolate) | 174 mcg |
Vitamin B12 (methylcobalamin) | 2.4 mcg |
Biotin | 16 mcg |
Iodine (potassium iodine) | 90 mcg |
Zinc (zinc citrate) | 1.6 mg |
Sodium | 10 mg |
Total Omega-3 Fatty Acids (derived from algal oil) | 85 mg |
Docosahexaenoic acid | 45 mg |
Eicosapentaenoic acid | 23 mg |
Inositol | 2 mg |
Non-active ingredients: Organic Cane Sugar, Organic Tapioca Syrup, Pectin, Gelatin, Citric Acid, Natural Flavors, Colors Added (Organic Annatto Extract, Organic Turmeric Extract, Organic Black Carrot Juice Concentrate) | |
- The placebo contains: Organic Cane Sugar, Organic Tapioca Syrup, Pectin, Citric Acid, Natural Flavors, Colors Added (Organic Annatto Extract)
Are there any side effects?
It is possible that your child could have problems or side effects that nobody knows about yet. There may be unknown risks with taking the study product. Potential side-effects of taking the study product may include:
- Gastrointestinal disturbance (such as stomach pain, nausea, vomiting, diarrhea, constipation)
- Trouble sleeping
- Skin rash
- Paleness
How Often and when do I need to take the study product?
- Your child will take two gummies with or without food once daily for the duration of the study starting on Day 1. It is recommended to take the two gummies in the morning for consistency
- If your child forgets to take the gummies, they should take them as soon as you or they remember. They are not to take more than two gummies a day.
- Save all unused and open packages and return them at each study visit. Study staff will count the remaining gummies to ensure proper study product consumption
How/When will I receive the product?
Product will be provided at no cost to yourself during your first visit, once you have been randomized into the study
How Long will the study last?
Once you receive your study product your participation will continue for approximately 56 days with 3 study visits.
What Does Randomization Mean?
Randomization is a process of assigning participants to different groups by chance (like flipping a coin). If eligible, your child will be enrolled into the study and will be randomized into 1 of 2 groups:
- Kids Plus Multi & Omegas group
- Placebo group
This is a triple-blind study, therefore neither you, your child, the study staff, nor the researchers analyzing the data will know which group they have been assigned to. This design ensures that the study’s results are unbiased. Neither you, your child, or the study staff can choose which group your child is in, ensuring the integrity of the trial. However, if it becomes necessary for your child’s health, the study staff can access this information.
Do I have to come into the clinic for any assessments?
Yes, you and your child will have 3 in–person visits over a 56 day period. Visit 1 is considered as day 0, Visit 2 will occur 28 days after the first visit, Visit 3 will occur 56 days after the first visit.
Who/How do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of $500, if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
Yes! KGK Science research staff will keep all of the personal medical information confidential to the extent required by law. You and your child will not be identified in any publication that may result from the study.
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
