About this trial
This is a pilot clinical study designed to evaluate the effects of a dietary supplement on selected blood-based nutritional biomarkers in healthy children aged 4 to 15 years.
Approximately 24 children will be screened and enrolled to account for potential dropouts, with a target of 20 participants completing the study. Eligible participants will attend a screening and baseline visit, followed by daily intake of the study supplement for 4 weeks. After the supplementation period, participants will return to the clinic for an end-of-study visit.
Blood samples will be collected at baseline and after 4 weeks to measure nutritional biomarkers, including vitamin D, vitamin B12, folate, omega-3 fatty acids, and standard blood count parameters. Additional assessments include height, weight, body mass index (BMI), and a socioeconomic questionnaire. Throughout the study, participants or their caregivers will record daily supplement intake, any medications taken, and any adverse events in a study diary.
The results of this pilot study will provide preliminary data on the effects of the dietary supplement on serum biomarkers in children.
Eligibility criteria
Qualifiers
Healthy Male and Females aged 4 - 15 years
NORMAL BMI /growth (per CDC growth tables) Between 5th - 85th percentile.
Able to read, understand, and complete the study questionnaire and records.
Able to understand the study procedures.
Disqualifiers
Immune insufficiency
Use of systemic corticosteroids or immunosuppressant drugs.
Any diseases or medications that might directly interfere in the study or put the subject's health under risk.
Currently taking any prescription medications or any dietary supplements including multivitamins
Trial design
Treatments tested in this trial
- Dietary Supplement (Kids Multi & Omegas)
Treatment groups
Sponsors and collaborators
SF Research Institute, Inc.
Lead sponsor
Smarty Pants Vitamins
Collaborator