Recruiting

Dietary Supplement

Sponsor:

SF Research Institute, Inc.

Code:

NCT07385144

Conditions

Nutritional Status

Serum Biomarkers

Eligibility Criteria

Sex: All

Age: 4 - 15

Healthy Volunteers: Accepted

Interventions

Dietary Supplement (Kids Multi & Omegas)

Study Details

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

Study ID

NCT07385144

Start date

Jan 30, 2026

Status verified date

Feb, 2026

Completion date

Mar 5, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 15

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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,

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dietary Supplement Group

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.

Interventions

Dietary Supplement (Kids Multi & Omegas)

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.

Primary outcome measure

  • Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4 [ Time Frame: Baseline (Day 1) and End of Study (Week 4) ]
  • Change in Serum Vitamin B12 From Baseline to Week 4 [ Time Frame: Baseline (Day 1) and End of Study (Week 4) ]
  • Change in Red Blood Cell Folate From Baseline to Week 4 [ Time Frame: Baseline (Day 1) and End of Study (Week 4) ]
  • Change in Plasma Omega-3 Fatty Acids From Baseline to Week 4 [ Time Frame: Baseline (Day 1) and End of Study (Week 4) ]
  • Change in Complete Blood Count Parameters From Baseline to Week 4 [ Time Frame: Baseline (Day 1) and End of Study (Week 4) ]

Central Contacts and Locations

Central contacts

Dr. John Ademola

415-845-4638jademola@sfinstitute.com

Locations

San Francisco Research Institute

Recruiting

San Francisco, California, United States, 94132

Contacts

Khaleeq Rehman

415-690-9641khaleeqr.sfinstitute@gmail.com

More Information

Sponsor

SF Research Institute, Inc.

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SF Research Institute, Inc. on 2026-02-04.