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NCT00862433 · ClinicalTrials.gov registry record · Phase 1

Vitamin E Pharmacokinetics and Biomarkers in Normal and Obese Women

A Phase 1 study of Obesity and Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT00862433: Completed Phase 1 study of Obesity and Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00862433 is a Phase 1 study of Obesity and Diabetes that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 50 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00862433, a Phase 1 study of Obesity and Diabetes, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

Background: * Vitamin E is an antioxidant that reduces the damaging effects of oxygen in the body. Most American men (90%) and women (96%) do not get enough vitamin E from their diets; however, the amount of vitamin E needed by the body has been studied only in men, not women. In addition, it is unknown whether another antioxidant, vitamin C, helps vitamin E in protecting the body. Because vitamin E is a fat-soluble vitamin, how much body fat a person has could affect the amount of vitamin E needed for protection. Objectives: This study has three arms to examine vitamin E requirements: * To determine the amount of fat required to get the best vitamin E absorption from a meal. * To determine the amount (i.e., best dose) of vitamin E that must be consumed before it can be measured in the blood. * To examine how vitamin E and vitamin C work together in the body, in conjunction with diet and vitamin supplements. Eligibility: * Arms 1 and 2: Women between the ages of 18 and 40 years who have a normal weight and body mass index (BMI) of 27 or less. * Arm 3: Women between the ages of 18 and 40 years who have a normal weight (BMI 27), who are overweight (BMI \> 27), or who are overweight (BMI \> 27) and have non insulin-dependent diabetes. Design: * Arm 1: Five studies, each lasting 1 month with 1 month off between studies (total study = 10 months). Participants will take 500 1,000 mg of vitamin C twice daily for 2 weeks before admission to the clinical center for 1 week. * Study 1: Participants will eat breakfast containing a known amount of fat, after which they will take a vitamin E pill as well as receive an IV injection of vitamin E. Other foods contain only negligible amounts of vitamin E. Blood and urine samples will measure levels of vitamin E and other substances. * Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however, the amount of fat in the breakfast will range from 0% to 40% in random order. During one of the studies, an a

Primary Outcome

Fractional vitamin E absorption and rates of plasma vitamin E disappearance after a single dose of oral and intravenous vitamin E

Conditions Studied

Obesity Diabetes Healthy Volunteers Fatty Liver

Interventions

  • OTHER Vitamin C
  • DRUG Alpha tocopherol
  • OTHER Vitamin E

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-10-10
Est. Completion 2022-05-03
Phase Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

490 total trials

What the finished NCT00862433 record still lists

NCT00862433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower).

The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Vitamin C is the first listed.

NCT00862433 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00862433 about?

NCT00862433 is a clinical study titled "Vitamin E Pharmacokinetics and Biomarkers in Normal and Obese Women". Background: * Vitamin E is an antioxidant that reduces the damaging effects of oxygen in the body. Most American men (90%) and women (96%) do not get enough vitamin E from their diets; however, the amount of vitamin E needed by the body has been studied only in men, not women. In addition, it is un...

What is the current status of trial NCT00862433?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-10-10. Estimated completion is 2022-05-03.

What conditions does trial NCT00862433 study?

This clinical trial studies the following conditions: Obesity, Diabetes, Healthy Volunteers, Fatty Liver.

What interventions are being tested in trial NCT00862433?

The interventions under investigation include: Vitamin C (OTHER), Alpha tocopherol (DRUG), Vitamin E (OTHER).

Who is sponsoring clinical trial NCT00862433?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00862433 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00862433's enrollment target sits among peer trials

50 714th of 1053 higher than 324 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00862433, the US trial registry maintained by the National Library of Medicine. NCT00862433 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.