A Study of a Dietary Supplement on Serum Biomarkers in Children

NCT07385144 | Recruiting

• 1 other identifier: SPV20251119 - 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutritional Status; Serum Biomarkers

Keywords

Dietary Supplement; Pediatric Nutrition; Nutritional Biomarkers; Vitamins; Omega-3 Fatty Acids; Vitamin D; Vitamin B12

Outcome Measures

Primary Outcomes (5)

• Change in Serum 25-Hydroxyvitamin D From Baseline to 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.

  Baseline (Day 1) and End of Study (Week 4)

• Change in Serum Vitamin B12 From Baseline to Week 4

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

  Baseline (Day 1) and End of Study (Week 4)

• Change in Red Blood Cell Folate From Baseline to Week 4

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

  Baseline (Day 1) and End of Study (Week 4)

• Change in Plasma Omega-3 Fatty Acids From Baseline to 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.

  Baseline (Day 1) and End of Study (Week 4)

• Change in Complete Blood Count Parameters From Baseline to 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.

  Baseline (Day 1) and End of Study (Week 4)

Secondary Outcomes (5)

• Change in Body Mass Index From Baseline to Week 4

  Baseline (Day 1) and End of Study (Week 4)

• Change in Height and Weight From Baseline to Week 4

  Baseline (Day 1) and End of Study (Week 4)

• Socioeconomic Status Assessment at Baseline

  Baseline (Day 1)

• Treatment Compliance and Diary Completion Over 4 Weeks

  Baseline (Day 1) through End of Study (Week 4)

• Incidence of Adverse Events During the Study Period

  Baseline (Day 1) through End of Study (Week 4)

Study Arms (1)

Dietary Supplement Group

EXPERIMENTAL

Participants in this arm will receive the investigational dietary supplement (Kids Multi \& Omegas) in gummy form. Subjects will be instructed to take two gummies once daily, with or without food, for a total duration of 4 weeks. Blood samples will be collected at baseline and at the end of the study to evaluate changes in selected serum nutritional biomarkers.

Dietary Supplement: Dietary Supplement (Kids Multi & Omegas)

Interventions

Dietary Supplement (Kids Multi & Omegas) DIETARY_SUPPLEMENT

The intervention consists of a gummy dietary supplement administered orally to healthy children. Participants will be instructed to take two gummies once daily, with or without food, starting on Day 1 and continuing for a total duration of 4 weeks. The supplement contains vitamins, minerals, and omega-3 fatty acids, including vitamin D, vitamin B12, folate, and polyunsaturated fatty acids (DHA and EPA). The intervention is evaluated by measuring serum nutritional biomarkers at baseline and after 4 weeks of supplementation.

Also known as: SPV20251119 - 01, Product A

Dietary Supplement Group

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Smarty Pants Vitamins: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: January 30, 2026
• Primary Completion: February 28, 2026
• Study Completion: March 5, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)