A Study of a Dietary Supplement on Serum Biomarkers in Children

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.

NCT Number	NCT07385144
Lead Sponsor	SF Research Institute, Inc. Collaborators: Smarty Pants Vitamins
Conditions	Nutritional Status, Serum Biomarkers
Enrollment	30 participants
Start Date	2026-01-30
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-03-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-04