Actively Recruiting

Phase Not Applicable
Age: 4Years - 15Years
All Genders
Healthy Volunteers
ID07385144

A Pilot Study Evaluating the Effects 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

N/A

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

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits: one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.

CONDITIONS

Brief 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
  • Body mass index (BMI) between 5th and 85th percentile according to CDC growth charts
  • Able to read, understand, and complete study questionnaires and records
  • Able to understand and comply with study procedures
  • Written informed consent from parent or guardian and assent from child
  • Willing to maintain current lifestyle habits and avoid new supplements during the study
  • Willingness 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 disease or medication that may interfere with the study or risk participant health
  • Current use of prescription medications or dietary supplements including multivitamins
  • Employees of the research institute, product brand owner, or manufacturers
  • Cardiovascular, chronic liver, thyroid, or kidney diseases; history of cancer; or any condition affecting ability to follow the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) combined screening and enrollment visit

Treatment

Duration - 4 weeks

Participants take the dietary supplement daily for 4 weeks while recording supplement intake, medications, and any adverse events in a daily diary.

2 visits (in-person): baseline and end-of-study

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

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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