A Study of a Dietary Supplement on Serum Biomarkers in Children

Conditions

• Nutritional Status
• Serum Biomarkers

Eligibility Criteria

Sex

ALL

Age

4 Years - 15 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Jan 30, 2026

Status verified

Feb 2026

Primary completion

Feb 28, 2026

Completion

Mar 5, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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) ]

Central Contacts

• Dr. John Ademola
  415-845-4638
  [email protected]

Locations (1)

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