Nutritional StatusNCT07385144
A Study of a Dietary Supplement on Serum Biomarkers in Children
A study testing Dietary Supplement (Kids Multi & Omegas) in people with Nutritional Status and Serum Biomarkers, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Serum Biomarkers
- What is being tested?
- Dietary Supplement (Kids Multi & Omegas)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
Khaleeq Rehman, 415-690-9641, khaleeqr.sfinstitute@gmail.com
About this study
Official title: A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children
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.
Read more
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.
Read the detailed description
This is a prospective, monadic pilot clinical study designed to evaluate the effects of a dietary supplement on serum nutritional biomarkers in healthy children. The study will be conducted at a single site, SF Research Institute, San Francisco, California.
Approximately 24 participants will be recruited to compensate for potential dropouts, with a target of 20 participants completing the study. Children aged 4 to 15 years who meet all inclusion and exclusion criteria will be eligible to participate. Recruitment will occur through the SF Research Institute database, social media, and public flyers.
The study consists of two clinic visits over a total study duration of approximately 4 weeks. At the Screening/Baseline Visit (Day 1), written informed consent from the parent or legal guardian and assent from the child will be obtained prior to any study procedures. Demographic information, medical history, socioeconomic status, and medication use will be collected, and eligibility criteria will be reviewed. Baseline anthropometric measurements, including height, weight, and body mass index (BMI), will be recorded.
At the baseline visit, participants will undergo phlebotomy for the collection of blood samples to assess nutritional biomarkers. Following completion of baseline assessments, eligible participants will be enrolled and provided with the investigational dietary supplement along with instructions for daily use over a 4-week period. Participants will also receive a daily diary to record supplement intake, concomitant medications (if taken), treatment compliance, and any adverse events.
The investigational product is a gummy dietary supplement, and participants will be instructed to take two gummies once daily, with or without food, starting on Day 1 and continuing for the duration of the study.
At the End-of-Study Visit (Week 4), participants will return to the clinic for review of the completed daily diary and assessment of compliance. A second blood sample will be collected for post-intervention biomarker analysis. Following completion of these procedures, participants will be discharged from the study.
Biomarker analyses will include measurements of 25-hydroxyvitamin D, serum vitamin B12, red blood cell folate, polyunsaturated fatty acids (including DHA and EPA), and a complete blood count. All laboratory analyses will be performed at Empire City Laboratories, Brooklyn, New York, USA.
All participants and their parents or guardians will have the opportunity to review the results of bloodwork, and instructions will be provided on how to contact the study physician for result-related questions.
- Conditions
- Nutritional Status, Serum Biomarkers
- Being tested
- Dietary Supplement (Kids Multi & Omegas)
- Keywords
- Dietary Supplement, Pediatric Nutrition, Nutritional Biomarkers, Vitamins, Omega-3 Fatty Acids, Vitamin D, Vitamin B12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement (Kids Multi & Omegas)Dietary supplement
Also called SPV20251119 - 01, Product A
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dietary Supplement (Kids Multi & Omegas) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and End of Study (Week 4)
Secondary outcomes (5)
Change in Body Mass Index From Baseline to Week 4
Change from baseline to Week 4 in body mass index (BMI), calculated using measured height and weight and compared with CDC growth tables for children.
Measured: Baseline (Day 1) and End of Study (Week 4)
Change in Height and Weight From Baseline to Week 4
Change from baseline to Week 4 in anthropometric measurements, including height and body weight, measured using a calibrated digital medical scale.
Measured: Baseline (Day 1) and End of Study (Week 4)
Socioeconomic Status Assessment at Baseline
Assessment of socioeconomic status using a structured questionnaire evaluating household income, parental education, living conditions, and access to resources.
Measured: Baseline (Day 1)
Treatment Compliance and Diary Completion Over 4 Weeks
Assessment of treatment compliance based on daily diary entries documenting supplement intake, concomitant medications (if taken), and study product use over the 4-week study period.
Measured: Baseline (Day 1) through End of Study (Week 4)
Incidence of Adverse Events During the Study Period
Monitoring and documentation of adverse events reported by participants or caregivers during the 4-week supplementation period.
Measured: Baseline (Day 1) through End of Study (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Smarty Pants Vitamins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385144
- Sponsor's protocol ID
- SPV20251119 - 01
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children
- ClinicalTrials.gov ID
- NCT07385144
- Acronym / sponsor ID
- SPV20251119 - 01
- Conditions
- Nutritional Status, Serum Biomarkers
- Keywords
- Dietary Supplement, Pediatric Nutrition, Nutritional Biomarkers, Vitamins, Omega-3 Fatty Acids, Vitamin D, Vitamin B12
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Smarty Pants Vitamins
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, monadic pilot clinical study designed to evaluate the effects of a dietary supplement on serum nutritional biomarkers in healthy children. The study will be conducted at a single site, SF Research Institute, San Francisco, California.
Approximately 24 participants will be recruited to compensate for potential dropouts, with a target of 20 participants completing the study. Children aged 4 to 15 years who meet all inclusion and exclusion criteria will be eligible to participate. Recruitment will occur through the SF Research Institute database, social media, and public flyers.
The study consists of two clinic visits over a total study duration of approximately 4 weeks. At the Screening/Baseline Visit (Day 1), written informed consent from the parent or legal guardian and assent from the child will be obtained prior to any study procedures. Demographic information, medical history, socioeconomic status, and medication use will be collected, and eligibility criteria will be reviewed. Baseline anthropometric measurements, including height, weight, and body mass index (BMI), will be recorded.
At the baseline visit, participants will undergo phlebotomy for the collection of blood samples to assess nutritional biomarkers. Following completion of baseline assessments, eligible participants will be enrolled and provided with the investigational dietary supplement along with instructions for daily use over a 4-week period. Participants will also receive a daily diary to record supplement intake, concomitant medications (if taken), treatment compliance, and any adverse events.
The investigational product is a gummy dietary supplement, and participants will be instructed to take two gummies once daily, with or without food, starting on Day 1 and continuing for the duration of the study.
At the End-of-Study Visit (Week 4), participants will return to the clinic for review of the completed daily diary and assessment of compliance. A second blood sample will be collected for post-intervention biomarker analysis. Following completion of these procedures, participants will be discharged from the study.
Biomarker analyses will include measurements of 25-hydroxyvitamin D, serum vitamin B12, red blood cell folate, polyunsaturated fatty acids (including DHA and EPA), and a complete blood count. All laboratory analyses will be performed at Empire City Laboratories, Brooklyn, New York, USA.
All participants and their parents or guardians will have the opportunity to review the results of bloodwork, and instructions will be provided on how to contact the study physician for result-related questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement Group | Experimental | Dietary Supplement: Dietary Supplement (Kids Multi & Omegas)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. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement (Kids Multi & Omegas)Also: SPV20251119 - 01, Product AThe 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. | Dietary supplement | Dietary Supplement Group |
Primary outcome
Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (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.
Change in Serum Vitamin B12 From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (Week 4)
Change from baseline to Week 4 in serum vitamin B12 (cobalamin) levels, measured by blood sample collection.
Change in Red Blood Cell Folate From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (Week 4)
Change from baseline to Week 4 in red blood cell (RBC) folate levels, measured by phlebotomy.
Change in Plasma Omega-3 Fatty Acids From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (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.
Change in Complete Blood Count Parameters From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (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.
5 secondary outcomes
Change in Body Mass Index From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (Week 4)
Change in Height and Weight From Baseline to Week 4
Time frame: Baseline (Day 1) and End of Study (Week 4)
Socioeconomic Status Assessment at Baseline
Time frame: Baseline (Day 1)
Treatment Compliance and Diary Completion Over 4 Weeks
Time frame: Baseline (Day 1) through End of Study (Week 4)
Incidence of Adverse Events During the Study Period
Time frame: Baseline (Day 1) through End of Study (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement (Kids Multi & Omegas) in people with Nutritional Status and Serum Biomarkers, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.