A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children
SF Research Institute, Inc.
Summary
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.
Description
This is a prospective, monadic pilot clinical study designed to evaluate the effects of a dietary supplement on serum nutritional biomarkers in healthy children. The study will be conducted at a single site, SF Research Institute, San Francisco, California. Approximately 24 participants will be recruited to compensate for potential dropouts, with a target of 20 participants completing the study. Children aged 4 to 15 years who meet all inclusion and exclusion criteria will be eligible to participate. Recruitment will occur through the SF Research Institute database, social media, and public f…
Eligibility
- Age range
- 4–15 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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. * Able to comply with all study requirements. * Written informed consent/Assent to participate in the study. * Agrees to maintain current lifestyle habits (diet, physical activity, medications, and sleep) as much as possible throughout the study and avoid taking new supplements * Willingness to actively participate in the study and to…
Interventions
- Dietary SupplementDietary Supplement (Kids Multi & Omegas)
The intervention consists of a gummy dietary supplement administered orally to healthy children. Participants will be instructed to take two gummies once daily, with or without food, starting on Day 1 and continuing for a total duration of 4 weeks. The supplement contains vitamins, minerals, and omega-3 fatty acids, including vitamin D, vitamin B12, folate, and polyunsaturated fatty acids (DHA and EPA). The intervention is evaluated by measuring serum nutritional biomarkers at baseline and after 4 weeks of supplementation.
Location
- San Francisco Research InstituteSan Francisco, California