What is this study of a dietary supplement trying to find out about children's nutritional status?

This study is evaluating how a gummy dietary supplement affects blood nutritional markers in healthy children aged 4 to 15 years. Researchers aim to see changes in vitamins and fatty acids using blood tests before and after 4 weeks of supplement use. The study is sponsored by SF Research Institute, Inc. and helps understand nutritional improvements in children.

Who may be eligible for this nutritional status clinical trial in children?

Children aged 4 to 15 years who are generally healthy with normal body weight and not currently taking medications or supplements may be eligible. Both boys and girls can participate if they can follow study procedures and attend scheduled visits. Please review eligibility criteria for more details.

Is there any cost to participate in this children's nutritional supplement trial?

Study-related care, including the dietary supplement and all trial visits, is provided at no cost. Personal expenses like travel may vary and are usually not covered. Participants can expect to receive the supplement and have blood tests at no charge.

Actively Recruiting

Phase Not Applicable

Age: 4Years - 15Years

All Genders

Healthy Volunteers

ID07385144

Pilot Study on the Effects of a Gummy Dietary Supplement on Blood Nutritional Markers in Healthy Children Aged 4 to 15

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

Participants Needed

Research Sites

N/A

Total Duration

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

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

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

Research Team

Dr. John Ademola

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