Measure Absorption of Vitamin D in BloodNCT03552653
Bioequivalence Study on Vitamin D in Healthy Adults
A study testing Vitafusion Extra Strength Vitamin D in people with Measure Absorption of Vitamin D in Blood, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet 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
- Measure Absorption of Vitamin D in Blood
- What is being tested?
- Vitafusion Extra Strength Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2017to 22 Dec 2017
- 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
- Female participants not of childbearing potential (hysterectomy, oophorectomy, bilateral tubal ligation, postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control including hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner
- BMI 18.5 to 29.9 kg/m2
- Agrees to maintain current level of physical activity throughout the study
- Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)
Who cannot join
- Women who are pregnant to be determined by UPT (uterine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study
- Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months
- Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders
- Unstable medical conditions as determined by the principal investigator
- Clinically significant abnormal laboratory results on CBC or BMP at screening
- Cancer chemotherapy/radiation treatment within the 3 months prior to enrollment
Show all 24Show fewer
- Metabolic disease
- History of kidney stones
- Use of prescription or over the counter products known to interact with vitamin D within 72 hours of randomization and during the trial such as aspirin and NSAIDs, aluminum, iron and proton pump inhibitors
- Use of acute over the counter medication within 72 hours of test product dosing
- Smokers
- Consumption of more than 2 alcoholic drinks per day
- Drug abuse within the past year
- Use of medicinal marijuana
- Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with HIV (human immunodeficiency virus)
- Use of St. John's wort in the last 30 days before randomization and during the study
- Use of vitamin D, multivitamins containing vitamin D, foods or beverages fortified with vitamin D and other natural health products containing vitamin D, or consumption of grapefruit/ grapefruit juice within 14 days of randomization and during the study
- Use of anticoagulants, barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
- History of blood/bleeding disorders
- Anemia of any etiology defined as hemoglobin < 140 g/L for males and < 123 g/L for females
- Blood donation in the past 3 months, or individual planning to donate blood during the study or within 30 days of completion of study
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to any ingredient in supplements provided during the study
- Individuals who are cognitively impaired and/or who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Church & Dwight Co., Inc.
Princeton, New Jersey, 08543
About this study
Official title: A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
The objective of this study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
Read the detailed description
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same dose of gummy and tablet supplementation.
- Conditions
- Measure Absorption of Vitamin D in Blood
- Being tested
- Vitafusion Extra Strength Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitafusion Extra Strength Vitamin DDietary supplement
Also called Nature Made Vitamin D
Monitor Vitamin D blood levels
| Study group | Role | What they receive |
|---|---|---|
| Vitafusion Extra Strength Vitamin D3 Gummy | Experimental | Single oral dose of gummy vitamin D3 to monitor vitamin D blood levels Receives: Dietary Supplement: Vitafusion Extra Strength Vitamin D |
| Nature Made Vitamin D3 Tablet | Active comparator | Single oral dose of tablet vitamin D3 to monitor vitamin D blood levels Receives: Dietary Supplement: Vitafusion Extra Strength Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absorption
A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)
Measured: baseline, 3, 6, 10, 24 and 48 hours
Secondary outcomes (1)
Absorption Rate
A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start26 Aug 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measure Absorption of Vitamin D in BloodStudies 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
- Model description
- Randomized, cross-over, comparator-controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, Study director, Church & Dwight Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552653
- Sponsor's protocol ID
- ST-7639N31
- Status last verified
- Jun 2018
- First submitted
- 2 May 2018
- Last updated
- 12 Jun 2018
- Results posted
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
- ClinicalTrials.gov ID
- NCT03552653
- Acronym / sponsor ID
- ST-7639N31
- Conditions
- Measure Absorption of Vitamin D in Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Study start
- 26 Aug 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 12 Jun 2018 (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 evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
Detailed description
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same dose of gummy and tablet supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, cross-over, comparator-controlled
| Arm | Type | Receives |
|---|---|---|
| Vitafusion Extra Strength Vitamin D3 Gummy | Experimental | Dietary Supplement: Vitafusion Extra Strength Vitamin DSingle oral dose of gummy vitamin D3 to monitor vitamin D blood levels |
| Nature Made Vitamin D3 Tablet | Active comparator | Dietary Supplement: Vitafusion Extra Strength Vitamin DSingle oral dose of tablet vitamin D3 to monitor vitamin D blood levels |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female participants not of childbearing potential (hysterectomy, oophorectomy, bilateral tubal ligation, postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control including hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner
- BMI 18.5 to 29.9 kg/m2
- Agrees to maintain current level of physical activity throughout the study
- Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)
Key exclusion criteria (24 listed)
- Women who are pregnant to be determined by UPT (uterine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study
- Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months
- Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders
- Unstable medical conditions as determined by the principal investigator
- Clinically significant abnormal laboratory results on CBC or BMP at screening
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 |
|---|---|---|
| Vitafusion Extra Strength Vitamin DAlso: Nature Made Vitamin DMonitor Vitamin D blood levels | Dietary supplement | Nature Made Vitamin D3 Tablet, Vitafusion Extra Strength Vitamin D3 Gummy |
Primary outcome
Mean Absorption
Time frame: baseline, 3, 6, 10, 24 and 48 hours
A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)
1 secondary outcome
Absorption Rate
Time frame: 0 to 48 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 12 Jun 2018.
- Individual participant dataSharing planned: No
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.
Annahita Ghassemi study director
Church & Dwight Company, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitafusion Extra Strength Vitamin D in people with Measure Absorption of Vitamin D in Blood, run by Church & Dwight Company, Inc. 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 4 inclusion and 24 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 12 Jun 2018. 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?
Mean Absorption (time frame: baseline, 3, 6, 10, 24 and 48 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 12 Jun 2018.