Vitamin A KineticsNCT03248700
Vitamin A Kinetics and Mathematical Modeling in American Women
A study testing Vitamin A tracer in people with Vitamin A Kinetics, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Women were given a vitamin A tracer, and blood was sampled to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine effects of study length on model outcomes. Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Kinetics
- What is being tested?
- Vitamin A tracer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2016
- 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 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI (18.5 - 24.9 kg/m2)
Who cannot join
- Smoker
- Pregnant
- Trying to become pregnant
- Lactating
- Weight loss > 4.5 kg during the past 3 months.
- Actively trying to lose weight
Show all 12Show fewer
- Inability to refrain from drinking alcohol when requested
- Amenorrhea
- Acute or chronic illness including hepatitis
- Current or previous history of anorexia or bulimia
- Concurrent participation in other studies
- Family member already enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutritional Sciences, University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
Women were given a vitamin A tracer, and blood was sampled to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine effects of study length on model outcomes.
Read the detailed description
This is a longitudinal study in which American women were given an oral, stable isotope tracer of vitamin A, and blood was sampled in a staggered, serial design to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis, and study truncation analysis was performed on data to investigate the factor of study duration on resulting vitamin A kinetic models and outputs related to vitamin A metabolism.
- Conditions
- Vitamin A Kinetics
- Being tested
- Vitamin A tracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A tracerOther
Also called 13C vitamin A, 13C retinyl acetate
A stable isotope tracer of vitamin A was given orally.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A tracer | Experimental | A stable isotope tracer of vitamin A was given orally. Receives: Other: Vitamin A tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total traced vitamin A mass
Total amount of endogenous vitamin A determined by mathematical model, (µmol).
Measured: Baseline through 152 days
Secondary outcomes (7)
Compartmental model complexity
Required number of compartments in mathematical model needed to adequately fit data.
Measured: Baseline through 152 days
Compartmental model fractional transfer coefficients
Model parameters adjusted to fit analytical data. Represents the fractional transfer from one compartment to another in the model, (pools/d, represented as L(i,j), the fraction of compartment J transferred to compartment I per day).
Measured: Baseline through 152 days
Serum vitamin A half-life
Half-life of vitamin A in serum, (d).
Measured: Baseline through 152 days
Vitamin A disposal rate
Daily loss or utilization of vitamin A, (µmol/d).
Measured: Baseline through 152 days
Vitamin A equilibration time and partitioning
Time taken for vitamin A to equilibrate with body stores, (d).
Measured: Baseline through 152 days
Vitamin A tracer partitioning
Body partitioning of tracer between serum and extravascular compartment(s), relative to total tracee mass. Calculated as a ratio of tracer-to-tracee ratio (TTR) in serum and extravascular stores, (TTR serum / TTR stores).
Measured: Baseline through 152 days
Vitamin A dietary intake
Vitamin A dietary intake by food frequency questionnaire, (µg retinol activity equivalents/d).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A KineticsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherry A Tanumihardjo, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248700
- Sponsor's protocol ID
- H-2008-0020
- Other IDs
- A074600, AG&LSC/NUTRITIONAL SCI/NUTRITI
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2017
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gannon BM, Valentine AR, Davis CR, Howe JA, Tanumihardjo SA. Duration of Retinol Isotope Dilution Studies with Compartmental Modeling Affects Model Complexity, Kinetic Parameters, and Calculated Vitamin A Stores in US Women. J Nutr. 2018 Aug 1;148(8):1387-1396. doi: 10.1093/jn/nxy095.
PubMed 30137477
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Kinetics and Mathematical Modeling in American Women
- ClinicalTrials.gov ID
- NCT03248700
- Acronym / sponsor ID
- H-2008-0020
- Conditions
- Vitamin A Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Aug 2017 (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.
Women were given a vitamin A tracer, and blood was sampled to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine effects of study length on model outcomes.
Detailed description
This is a longitudinal study in which American women were given an oral, stable isotope tracer of vitamin A, and blood was sampled in a staggered, serial design to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis, and study truncation analysis was performed on data to investigate the factor of study duration on resulting vitamin A kinetic models and outputs related to vitamin A metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin A tracer | Experimental | Other: Vitamin A tracerA stable isotope tracer of vitamin A was given orally. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI (18.5 - 24.9 kg/m2)
Key exclusion criteria (12 listed)
- Smoker
- Pregnant
- Trying to become pregnant
- Lactating
- Weight loss > 4.5 kg during the past 3 months.
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 |
|---|---|---|
| Vitamin A tracerAlso: 13C vitamin A, 13C retinyl acetateA stable isotope tracer of vitamin A was given orally. | Other | Vitamin A tracer |
Primary outcome
Total traced vitamin A mass
Time frame: Baseline through 152 days
Total amount of endogenous vitamin A determined by mathematical model, (µmol).
7 secondary outcomes
Compartmental model complexity
Time frame: Baseline through 152 days
Compartmental model fractional transfer coefficients
Time frame: Baseline through 152 days
Serum vitamin A half-life
Time frame: Baseline through 152 days
Vitamin A disposal rate
Time frame: Baseline through 152 days
Vitamin A equilibration time and partitioning
Time frame: Baseline through 152 days
Vitamin A tracer partitioning
Time frame: Baseline through 152 days
Vitamin A dietary intake
Time frame: Baseline
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 31 Oct 2019.
- Derived from this study: PubMed 30137477Gannon BM, Valentine AR, Davis CR, Howe JA, Tanumihardjo SA. Duration of Retinol Isotope Dilution Studies with Compartmental Modeling Affects Model Complexity, Kinetic Parameters, and Calculated Vitamin A Stores in US Women. J Nutr. 2018 Aug 1;148(8):1387-1396. doi: 10.1093/jn/nxy095.
- 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.
Sherry A Tanumihardjo, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A tracer in people with Vitamin A Kinetics, run by University of Wisconsin, Madison 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 1 inclusion and 12 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 31 Oct 2019. 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?
Total traced vitamin A mass (time frame: Baseline through 152 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248700, which also lists 1 linked publication.
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 31 Oct 2019.