Children's multivitamin and omega-3 supplement to improve blood nutrition markers
A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children
We will try a daily children's multivitamin with omega-3 for four weeks to see if it raises blood nutrient levels in healthy kids 4 to 15 years old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | SF Research Institute, Inc. Research network |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07385144 on ClinicalTrials.gov |
What this trial studies
This single-arm, prospective pilot at a single San Francisco site will enroll about 24 healthy children (target 20 completers) aged 4–15 who are not taking other supplements or prescription medications. After consent and baseline assessments (medical history, socioeconomic questionnaire, height/weight/BMI) participants provide a blood sample for vitamin D, B12, folate, omega‑3 fatty acids, and standard blood counts. Participants take the provided multivitamin-plus-omega‑3 supplement daily for four weeks while caregivers log daily intake, medications, and any adverse events. Participants return after four weeks for repeat anthropometrics and blood testing to compare baseline and end-of-study biomarker levels.
Who should consider this trial
Good fit: Healthy boys and girls aged 4–15 with BMI between the 5th and 85th percentiles who are not currently taking vitamins or prescription medications and can attend two clinic visits.
Not a fit: Children with immune insufficiency, those on systemic corticosteroids or immunosuppressants, those taking prescription medications or current dietary supplements, or those outside the specified BMI range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the supplement could raise common nutritional biomarkers and offer an easy way to address low vitamin or omega‑3 levels in healthy children.
How similar studies have performed: Prior nutrition studies have shown multivitamin and omega‑3 supplements can increase corresponding blood nutrient concentrations, so this pilot builds on modest existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
San Francisco, California
- San Francisco Research Institute — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Dr. John Ademola
- Email: jademola@sfinstitute.com
- Phone: 415-845-4638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.