Actively Recruiting

Phase Not Applicable
Age: 4Years - 15Years
All Genders
Healthy Volunteers
NCT07385144

A Study of a Dietary Supplement on Serum Biomarkers in Children

Led by SF Research Institute, Inc. · Updated on 2026-02-04

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

S

SF Research Institute, Inc.

Lead Sponsor

S

Smarty Pants Vitamins

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of a Dietary Supplement on Serum Biomarkers in Children

Who Can Participate

Age: 4Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females aged 4 to 15 years
  • Normal BMI/growth between 5th and 85th percentile according to CDC growth tables
  • Able to read, understand, and complete study questionnaires and records
  • Able to understand study procedures
  • Able to meet all study requirements
  • Written informed consent from parent/guardian and assent from child
  • Willing to maintain current lifestyle habits including diet, physical activity, medications, and sleep during the study
  • Willing to avoid starting new supplements during the study
  • Willing to actively participate and attend scheduled visits
Not Eligible

You will not qualify if you...

  • Immune insufficiency
  • Use of systemic corticosteroids or immunosuppressant drugs
  • Any diseases or medications that could interfere with the study or risk participant's health
  • Currently taking prescription medications or dietary supplements including multivitamins
  • Employees of the study institute, product brand owner, or manufacturers
  • Cardiovascular, chronic liver, thyroid, or kidney diseases
  • History of cancer
  • Any condition affecting ability to follow study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

San Francisco Research Institute

San Francisco, California, United States, 94132

Actively Recruiting

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Research Team

D

Dr. John Ademola

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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