Vitamin A Kinetics and Mathematical Modeling in American Women

NCT ID: NCT03248700

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Vitamin A Kinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin A tracer

A stable isotope tracer of vitamin A was given orally.

Group Type EXPERIMENTAL

Vitamin A tracer

Intervention Type OTHER

A stable isotope tracer of vitamin A was given orally.

Interventions

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Vitamin A tracer

A stable isotope tracer of vitamin A was given orally.

Intervention Type OTHER

Other Intervention Names

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13C vitamin A 13C retinyl acetate

Eligibility Criteria

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Inclusion Criteria

* BMI (18.5 - 24.9 kg/m2)

Exclusion Criteria

* Smoker
* Pregnant
* Trying to become pregnant
* Lactating
* Weight loss \> 4.5 kg during the past 3 months.
* Actively trying to lose weight
* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherry A Tanumihardjo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Department of Nutritional Sciences, University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30137477 (View on PubMed)

Other Identifiers

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A074600

Identifier Type: OTHER

Identifier Source: secondary_id

AG&LSC/NUTRITIONAL SCI/NUTRITI

Identifier Type: OTHER

Identifier Source: secondary_id

H-2008-0020

Identifier Type: -

Identifier Source: org_study_id

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