Dietary Supplement Study for Children's Nutritional Biomarkers

This study is looking at how a dietary supplement called "Kids Multi & Omegas" affects certain nutrients in healthy children aged 4 to 15. Researchers want to see if taking two gummies once daily for four weeks can change levels of vitamin D, vitamin B12, and folate in the blood. The main goal is to measure these changes from the beginning to the end of the four-week period. About 20 children are expected to complete the study. To join, children need to be healthy, have a normal Body Mass Index (BMI), and be able to understand and follow study instructions. The current status of the study is unclear.

Study design
This is a pilot clinical study designed to evaluate the effects of a dietary supplement in healthy children. It is a single-site study aiming for 20 participants to complete.
What's involved
You would attend a screening and baseline visit, take two gummies daily for 4 weeks, and then return for an end-of-study visit. Blood samples will be collected at the beginning and end of the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks, with measurements taken at baseline (Day 1) and at the end of the study (Week 4).

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NCT07385144

A Study of a Dietary Supplement on Serum Biomarkers in Children

Recruiting
NAAges 4–15InterventionalTreatment
SF Research Institute, Inc.
~30 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Dietary Supplement (Kids Multi & Omegas)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4
Measured over Baseline (Day 1) and End of Study (Week 4)
+4 more outcomes measured
Nutritional Status
Serum Biomarkers
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

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

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,
  • Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4Baseline (Day 1) and End of Study (Week 4)

    Change from baseline to Week 4 in serum 25-hydroxyvitamin D (25\[OH\]D), measured by phlebotomy as a marker of vitamin D status.

  • Change in Serum Vitamin B12 From Baseline to Week 4Baseline (Day 1) and End of Study (Week 4)

    Change from baseline to Week 4 in serum vitamin B12 (cobalamin) levels, measured by blood sample collection.

  • Change in Red Blood Cell Folate From Baseline to Week 4Baseline (Day 1) and End of Study (Week 4)

    Change from baseline to Week 4 in red blood cell (RBC) folate levels, measured by phlebotomy.

  • Change in Plasma Omega-3 Fatty Acids From Baseline to Week 4Baseline (Day 1) and End of Study (Week 4)

    Change from baseline to Week 4 in plasma polyunsaturated fatty acids, including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), measured by blood sample collection.

  • Change in Complete Blood Count Parameters From Baseline to Week 4Baseline (Day 1) and End of Study (Week 4)

    Change from baseline to Week 4 in complete blood count (CBC) parameters, including red blood cell count, hemoglobin, hematocrit, white blood cell count, and platelet count.