A Study of a Dietary Supplement on Serum Biomarkers in Children (NCT07385144) | Clinical Trial Compass
RecruitingNot Applicable
A Study of a Dietary Supplement on Serum Biomarkers in Children
United States30 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range
4 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 come to the scheduled visits.
Exclusion Criteria:
* 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4
Timeframe: Baseline (Day 1) and End of Study (Week 4)
2
Change in Serum Vitamin B12 From Baseline to Week 4
Timeframe: Baseline (Day 1) and End of Study (Week 4)
3
Change in Red Blood Cell Folate From Baseline to Week 4
Timeframe: Baseline (Day 1) and End of Study (Week 4)
4
Change in Plasma Omega-3 Fatty Acids From Baseline to Week 4
Timeframe: Baseline (Day 1) and End of Study (Week 4)
5
Change in Complete Blood Count Parameters From Baseline to Week 4
Timeframe: Baseline (Day 1) and End of Study (Week 4)