Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement
NCT ID: NCT05646368
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2022-12-23
2023-05-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
NCT05060367
Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
NCT03146273
Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.
NCT06505408
Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
NCT03146312
Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement
NCT04112732
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Formulation #1 of a multivitamin/mineral supplement
Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement
Formulation #1
Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement
Formulation #2 of a multivitamin/mineral supplement
Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement
Formulation #2
Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Formulation #1
Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement
Formulation #2
Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject has a BMI of ≥18.50 and \<30.00 kg/m2.
3. Subject is a non-smoker (at least 6 months) and has no plans to start smoking (or vaping) during the study period.
4. Subject is judged to be in good health based on medical history and routine laboratory tests.
5. Subject has a score of ≥7 on the Vein Access Scale.
6. Subject agrees to abstain from alcohol consumption and vigorous physical activity for at least 24 h prior to all test visits.
7. Subject understands the study procedures, and is willing to complete them, and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria
2. Individual has a serum folate concentration outside of the normal range (\>3.0 ng/ml) at visit 1, day -7.
3. Individual has a serum zinc concentration outside of the normal range (44-115 μg/dL) on visit 1, day -7.
4. Individual has a serum magnesium concentration outside of the normal range (1.6 - 2.3 mg/dL) on visit 1, day -7.
5. Individual has a serum vitamin B12 concentration outside of the normal range (232-1245 pg/mL) on visit 1, day -7.
6. Individual has a hemoglobin outside of the normal range (13.0-17.7 g/dL).
7. Individual has had a blood transfusion during the 3 months prior to the screening visit (visit 1, day -7).
8. Individual has any gastrointestinal condition that would potentially interfere with absorption of the study product (e.g., inflammatory bowel disease, celiac disease, history of gastric bypass surgery, chronic gastritis).
9. Individual has a history or presence of clinically important medical diagnosis, in the opinion of the Principal Investigator.
10. Individual has an active infection or sign/symptoms of an infection. The test days (visits 2-5) will be rescheduled to allow the subject to be symptom-free of any type of systemic infection for at least five days.
11. Individual has recent use of antibiotics (within 7 days of visit 2, day 0) and throughout the study period. The test days will be rescheduled to allow the subject to wash out the antibiotic for at least 7 days.
12. Individual has unstable use (initiation or change in dose) within four weeks of visit 2 (day 0) of antihypertensive medications, thyroid hormone replacement, hormonal contraceptives, or hormone therapy.
13. Individual has consumed any dietary supplements (including all vitamin/mineral supplements) within one week of visit 2, day 0 and throughout the study period.
14. Individual has received an intramuscular injection of vitamin B12 within 6 months of visit 2, day 0.
15. Subject is female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
16. Individual has consumed alcoholic beverages within 24 h of each test day visit (visits 2-5).
17. Individual has used medications known to interfere with vitamin and mineral absorption within one week of visit 2, day 0 and throughout the study period, including but not limited to, aspirin, anti-inflammatories, antacids, histamine 2 receptor antagonists, and proton-pump inhibitors.
18. Individual is taking an anticonvulsant medication.
19. Individual has extreme dietary habits, as judged by the Investigator (e.g., vegan, Atkins, very low carbohydrate/very high protein, etc.).
20. Individual has history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional.
21. Individual has any major trauma or surgical event within 12 weeks of the screening visit (visit 1, day -7).
22. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening (visit 1, day -7). One re-test will be allowed on a separate day prior to visit 2, day 0 for subjects whose blood pressure exceeds either of these cut points at visit 1.
23. Individual has a recent history or strong potential for drug or alcohol abuse or has a positive urine drug screen.
24. Individual has a known allergy to any ingredients in the study products or provided meals/snacks.
25. Individual has a condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmavite LLC
INDUSTRY
Midwest Center for Metabolic and Cardiovascular Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kevin C Maki, PhD
Role: STUDY_DIRECTOR
MB Clinical Research & Consulting
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Awareness
Port Saint Lucie, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB-2113
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.