A Study of a Dietary Supplement on Serum Biomarkers in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorSF Research Institute, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dietary Supplement (Kids Multi & Omegas)
Dietary supplementThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Dietary Supplement GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1) and End of Study (Week 4)2
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.
Time frame
Baseline (Day 1) and End of Study (Week 4)3
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.
Time frame
Baseline (Day 1) and End of Study (Week 4)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.
Time frame
Baseline (Day 1) and End of Study (Week 4)Secondary outcomes
1
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.
Time frame
Baseline (Day 1) and End of Study (Week 4)2
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.
Time frame
Baseline (Day 1) and End of Study (Week 4)3
Socioeconomic Status Assessment at Baseline
Assessment of socioeconomic status using a structured questionnaire evaluating household income, parental education, living conditions, and access to resources.
Time frame
Baseline (Day 1)4
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.
Time frame
Baseline (Day 1) through End of Study (Week 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Smarty Pants Vitamins
Collaborator
Source ClinicalTrials.gov