BioavailabilityNCT05646368
Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement
A study testing Formulation #1 and Formulation #2 in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Formulation #1 and Formulation #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2022to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female, 18 to 45 years of age, inclusive.
- Subject has a BMI of ≥18.50 and <30.00 kg/m2.
- Subject is a non-smoker (at least 6 months) and has no plans to start smoking (or vaping) during the study period.
- Subject is judged to be in good health based on medical history and routine laboratory tests.
- Subject has a score of ≥7 on the Vein Access Scale.
- Subject agrees to abstain from alcohol consumption and vigorous physical activity for at least 24 h prior to all test visits.
- 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.
Who cannot join
- Individual has a history of difficulty swallowing capsules or large pills.
- Individual has a serum folate concentration outside of the normal range (>3.0 ng/ml) at visit 1, day -7.
- Individual has a serum zinc concentration outside of the normal range (44-115 μg/dL) on visit 1, day -7.
- Individual has a serum magnesium concentration outside of the normal range (1.6 - 2.3 mg/dL) on visit 1, day -7.
- Individual has a serum vitamin B12 concentration outside of the normal range (232-1245 pg/mL) on visit 1, day -7.
- Individual has a hemoglobin outside of the normal range (13.0-17.7 g/dL).
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- Individual has had a blood transfusion during the 3 months prior to the screening visit (visit 1, day -7).
- 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).
- Individual has a history or presence of clinically important medical diagnosis, in the opinion of the Principal Investigator.
- 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.
- 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.
- 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.
- Individual has consumed any dietary supplements (including all vitamin/mineral supplements) within one week of visit 2, day 0 and throughout the study period.
- Individual has received an intramuscular injection of vitamin B12 within 6 months of visit 2, day 0.
- 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.
- Individual has consumed alcoholic beverages within 24 h of each test day visit (visits 2-5).
- 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.
- Individual is taking an anticonvulsant medication.
- Individual has extreme dietary habits, as judged by the Investigator (e.g., vegan, Atkins, very low carbohydrate/very high protein, etc.).
- Individual has history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional.
- Individual has any major trauma or surgical event within 12 weeks of the screening visit (visit 1, day -7).
- 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.
- Individual has a recent history or strong potential for drug or alcohol abuse or has a positive urine drug screen.
- Individual has a known allergy to any ingredients in the study products or provided meals/snacks.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Crossover Study to Assess Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement in Healthy Adults
The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults.
- Conditions
- Bioavailability
- Being tested
- Formulation #1, Formulation #2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation #1Dietary supplement
Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement
Formulation #2Dietary supplement
Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement
| Study group | Role | What they receive |
|---|---|---|
| Formulation #1 of a multivitamin/mineral supplement | Experimental | Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement Receives: Dietary Supplement: Formulation #1 |
| Formulation #2 of a multivitamin/mineral supplement | Active comparator | Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement Receives: Dietary Supplement: Formulation #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted geometric mean ratio (GMR) for area under the curve (AUC) from 0 to 2 h for plasma folate
Changes in GMR for baseline-adjusted AUC for plasma folate
Measured: Baseline to 2 hours
Secondary outcomes (7)
Unadjusted and baseline-adjusted AUC from 0 to 2 h for select nutrients in plasma
Changes in unadjusted and baseline-adjusted AUC for select nutrients in plasma
Measured: Baseline to 2 hours
Unadjusted and baseline-adjusted GMRs for AUC from 0 to 2 h for select nutrients in plasma
Changes in unadjusted and baseline-adjusted GMRs for AUC for select nutrients in plasma
Measured: Baseline to 2 hours
Unadjusted and baseline-adjusted AUC from 0 to 8 h for select nutrients in plasma
Changes in unadjusted and baseline-adjusted AUC for select nutrients in plasma
Measured: Baseline to 8 hours
Unadjusted and baseline-adjusted GMRs for AUC from 0 to 8 h for select nutrients in plasma
Changes in unadjusted and baseline-adjusted GMRs for AUC for select nutrients in plasma
Measured: Baseline to 8 hours
Maximum concentrations of select nutrients in plasma
Differences between study products in unadjusted and baseline-adjusted maximum concentrations of select nutrients in plasma
Measured: Baseline to 8 hours
Time (in hours) to reach the maximum concentration of select nutrients in plasma
Differences between study products in the time to reach the maximum concentration of select nutrients in plasma
Measured: Baseline to 8 hours
Concentration of a select nutrient in urine
Differences between study products in the concentration of a select nutrient in urine
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start23 Dec 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmavite LLC
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, MB Clinical Research & Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646368
- Sponsor's protocol ID
- MB-2113
- Status last verified
- May 2023
- First submitted
- 1 Dec 2022
- Last updated
- 17 May 2023
- 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 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Study to Assess Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement in Healthy Adults
- ClinicalTrials.gov ID
- NCT05646368
- Acronym / sponsor ID
- MB-2113
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Pharmavite LLC
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 12 Dec 2022 (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.
The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation #1 of a multivitamin/mineral supplement | Experimental | Dietary Supplement: Formulation #1Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement |
| Formulation #2 of a multivitamin/mineral supplement | Active comparator | Dietary Supplement: Formulation #2Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is male or female, 18 to 45 years of age, inclusive.
- Subject has a BMI of ≥18.50 and <30.00 kg/m2.
- Subject is a non-smoker (at least 6 months) and has no plans to start smoking (or vaping) during the study period.
- Subject is judged to be in good health based on medical history and routine laboratory tests.
- Subject has a score of ≥7 on the Vein Access Scale.
Key exclusion criteria (25 listed)
- Individual has a history of difficulty swallowing capsules or large pills.
- Individual has a serum folate concentration outside of the normal range (>3.0 ng/ml) at visit 1, day -7.
- Individual has a serum zinc concentration outside of the normal range (44-115 μg/dL) on visit 1, day -7.
- Individual has a serum magnesium concentration outside of the normal range (1.6 - 2.3 mg/dL) on visit 1, day -7.
- Individual has a serum vitamin B12 concentration outside of the normal range (232-1245 pg/mL) on visit 1, day -7.
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 |
|---|---|---|
| Formulation #1Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement | Dietary supplement | Formulation #1 of a multivitamin/mineral supplement |
| Formulation #2Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement | Dietary supplement | Formulation #2 of a multivitamin/mineral supplement |
Primary outcome
Baseline-adjusted geometric mean ratio (GMR) for area under the curve (AUC) from 0 to 2 h for plasma folate
Time frame: Baseline to 2 hours
Changes in GMR for baseline-adjusted AUC for plasma folate
7 secondary outcomes
Unadjusted and baseline-adjusted AUC from 0 to 2 h for select nutrients in plasma
Time frame: Baseline to 2 hours
Unadjusted and baseline-adjusted GMRs for AUC from 0 to 2 h for select nutrients in plasma
Time frame: Baseline to 2 hours
Unadjusted and baseline-adjusted AUC from 0 to 8 h for select nutrients in plasma
Time frame: Baseline to 8 hours
Unadjusted and baseline-adjusted GMRs for AUC from 0 to 8 h for select nutrients in plasma
Time frame: Baseline to 8 hours
Maximum concentrations of select nutrients in plasma
Time frame: Baseline to 8 hours
Time (in hours) to reach the maximum concentration of select nutrients in plasma
Time frame: Baseline to 8 hours
Concentration of a select nutrient in urine
Time frame: Baseline to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- 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. This study is not recruiting at the moment.
Kevin C Maki, PhD study director
MB Clinical Research & Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formulation #1 and Formulation #2 in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research 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 7 inclusion and 25 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: finished, as of the sponsor's last update on 17 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-adjusted geometric mean ratio (GMR) for area under the curve (AUC) from 0 to 2 h for plasma folate (time frame: Baseline to 2 hours). 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 17 May 2023.