Dietary Supplement for Nutritional Status in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a dietary supplement affects certain nutrients in the blood of healthy children aged 4 to 15. The goal is to determine if the supplement, taken as gummies, can improve levels of vitamin D, vitamin B12, and omega-3s. Participants will take the supplement daily for four weeks, with blood samples collected before and after to check for changes. Children who are healthy, have a normal growth pattern, and can follow the study rules are eligible to participate. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the potential benefits of dietary supplements in children.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription medications or dietary supplements, including multivitamins, to participate in this trial.
What prior data suggests that this dietary supplement is safe for children?
Research shows that the dietary supplement Kids Multi & Omegas is generally safe for children. Studies on children's multivitamin and mineral supplements have found a low risk of harmful effects, indicating they are safe to use. Additionally, research on omega-3 fatty acids, a key component of this supplement, shows they are well-tolerated by children.
However, while these supplements are usually safe, they might not be necessary for every child. Parents should consider whether their child truly needs a supplement and consult a healthcare provider if uncertain. Always follow the recommended dosage to minimize any risk of side effects.12345Why are researchers excited about this trial?
Most treatments for improving children's nutritional status involve changes in diet or the use of conventional vitamin pills. However, the investigational treatment, Kids Multi & Omegas gummies, stands out because it combines essential vitamins with omega fatty acids in a kid-friendly gummy form. This delivery method makes it easier for kids to take and enjoy, potentially improving adherence to the regimen. Researchers are excited because this approach could provide a more convenient and appealing way to address nutritional deficiencies in children, potentially leading to better health outcomes.
What evidence suggests that this dietary supplement is effective for improving nutritional status in children?
Research has shown that omega-3 supplements can enhance brain function in children, particularly in decision-making and problem-solving. These nutrients are often part of multivitamins, which many children already consume. Studies have found that multivitamin supplements are popular among children, with many taking them regularly. While this trial examines nutritional markers, ingredients like omega-3s and vitamins are known to support overall health. The Kids Multi & Omegas supplement, provided to participants in this trial, might improve these nutritional markers in children, based on the positive effects observed in similar products.12678
Are You a Good Fit for This Trial?
This trial is for healthy children aged 4 to 15 with normal growth, who can follow the study's rules and maintain their usual lifestyle. They must not start new supplements during the study and should be able to understand the procedures and record information.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including demographic information, medical history, and blood sample collection for nutritional biomarkers
Treatment
Participants take the dietary supplement daily for 4 weeks, with daily diary entries for compliance and adverse events
End-of-Study
Final assessments including blood sample collection for post-intervention biomarker analysis and review of daily diary
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dietary Supplement (Kids Multi & Omegas)
Trial Overview
The trial tests a dietary supplement (Kids Multi & Omegas) on blood nutritional markers in children. It involves daily intake of the supplement for four weeks, with clinic visits at the beginning and end for blood sample collection to measure vitamins and omega-3 levels.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this arm will receive the investigational dietary supplement (Kids Multi \& Omegas) in gummy form. Subjects will be instructed to take two gummies once daily, with or without food, for a total duration of 4 weeks. Blood samples will be collected at baseline and at the end of the study to evaluate changes in selected serum nutritional biomarkers.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SF Research Institute, Inc.
Lead Sponsor
Smarty Pants Vitamins
Collaborator
Citations
Dietary Supplement for Nutritional Status in Children
The trial tests a dietary supplement (Kids Multi & Omegas) on blood nutritional markers in children. It involves daily intake of the supplement for four weeks, ...
Use of Dietary Supplements and Influencing Factors in Children
This study aims to determine the use of dietary supplements by children, the factors affecting this use, and the attitudes of parents about these products.
Cognitive Effects of Omega-3 Supplements in Children ...
We hypothesize that after 12 months of intervention, children consuming omega-3 fatty acids will have statistically significant higher improvement in scores on ...
Impact of Omega-3 Fatty Acids on Cognitive Outcomes in ...
This systematic analysis shows that omega-3 fatty acid supplementation may improve cognitive outcomes in children with ASD, namely executive functioning, ...
Prevalence and predictors of children's dietary supplement ...
A total of 37% of subjects used dietary supplements, 31% of subjects used multivitamin mineral (MVM) products exclusively, 4% of subjects used single ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT01221714?term=AREA%5BBasicSearch%5D(VITAMIN%20A)&rank=3Toxicity and Safety Evaluation of an Omega-3 Fatty Acid ...
There are multiple potential sources of oxidative injury to include, but not limited to space radiation, noise, fuel reaction products, planetary regolith, and ...
7.
researchgate.net
researchgate.net/publication/370794227_Toxic_elements_in_children's_multivitamin-multimineral_supplements_and_the_health_risks_they_poseToxic elements in children's multivitamin-multimineral ...
The THQ and HI values were below 1, indicating that these products were safe for consumption by children. The potential cancer risks associated with exposure to ...
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