A Study of a Dietary Supplement on Serum Biomarkers in Children
A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children
SF Research Institute, Inc.
30 participants
Jan 30, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 come to the scheduled visits.
Exclusion Criteria6
- 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
- Employees of the institute or the brand owner or the manufacturers of the product
- Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07385144