Dietary Supplement Study for Children's Nutritional Biomarkers
This study is looking at how a dietary supplement called "Kids Multi & Omegas" affects certain nutrients in healthy children aged 4 to 15. Researchers want to see if taking two gummies once daily for four weeks can change levels of vitamin D, vitamin B12, and folate in the blood. The main goal is to measure these changes from the beginning to the end of the four-week period. About 20 children are expected to complete the study. To join, children need to be healthy, have a normal Body Mass Index (BMI), and be able to understand and follow study instructions. The current status of the study is unclear.
- Study design
- This is a pilot clinical study designed to evaluate the effects of a dietary supplement in healthy children. It is a single-site study aiming for 20 participants to complete.
- What's involved
- You would attend a screening and baseline visit, take two gummies daily for 4 weeks, and then return for an end-of-study visit. Blood samples will be collected at the beginning and end of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 4 weeks, with measurements taken at baseline (Day 1) and at the end of the study (Week 4).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of a Dietary Supplement on Serum Biomarkers in Children
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Change in Serum 25-Hydroxyvitamin D From Baseline to Week 4Baseline (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 4Baseline (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 4Baseline (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 4Baseline (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 4Baseline (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.