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Obesity / Vitamin E / Fatty Liver · Phase 1 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 1 registry record documenting a planned trial of vitamin E pharmacokinetics and biomarkers in normal and obese women aged 18–40 years. No results are reported in this registry entry; the record describes only study design, eligibility, and intervention protocols. Clinicians and researchers should not draw any conclusions about efficacy, safety, or vitamin E requirements from this registration alone.
Phase 1, Interventional, Non Randomized, Factorial, Open label, Prevention purpose. Diabetes, Fatty Liver, Obesity, Healthy Volunteers; Female; age from 18 Years; to 55 Years. Intervention: Arm 1; Arm 2; Arm 3; NAFLD sub-study. n = 50. 1 site: United States.
This is a completed Phase 1 registry record documenting a planned trial of vitamin E pharmacokinetics and biomarkers in normal and obese women aged 18–40 years. No results are reported in this registry entry; the record describes only study design, eligibility, and intervention protocols. Clinicians and researchers should not draw any conclusions about efficacy, safety, or vitamin E requirements from this registration alone.
This is a registry record only; no results, outcomes, or safety data are reported.
The source did not state who this applies to in practice.
This is a completed Phase 1 interventional trial registration with no results posted; it describes planned conduct and enrollment only, permitting no inference of efficacy or safety outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00862433). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 50 participants (ACTUAL). Conditions: Diabetes, Fatty Liver, Obesity, Healthy Volunteers. Interventions: DRUG: Alpha tocopherol; OTHER: Vitamin E; OTHER: Vitamin C. Primary outcome measures: Measure Vitamin E Kinetics , q min, hrly, daily. Brief 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 adipose tissue biopsy will be collected to determine how much vitamin E is in the tissues. * Arm 2: Five studies, each lasting 1 month with 1 month off between studies (total study = 10 months). Preparation for Arm 2 is the same as in Arm 1. The proportion of fat, muscle, and water in the body will also be measured. * Study 1: Participants will eat breakfast containing 30% fat, after which they will take a vitamin E pill as well as receive an IV injection of vitamin E. Conditions and procedures are the same as in Arm 1. * Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however, the amount of vitamin E in the breakfast will range from 2 to 30 mg in random order. * Arm 3: Outpatient (2 to 6 weeks) and inpatient studies (4 to 6 weeks). * Outpatient study: Participants will take 500 1,000 mg of vitamin C daily and provide blood and urine samples, as well as an adipose tissue sample. * Inpatient studies: Two vitamin E inpatient studies. Before these begin, participants vitamin C blood levels will be reduced by means of a diet low in vitamin C. Blood tests will determine how quickly vitamin C leaves the body. Once the vitamin C level is reduced, the first vitamin E study will begin. Study A: The procedure for this study is the same as in Arm 2, Study 1. Study B: The procedure for this study is the same as in Study A, except that the participants blood vitamin C levels will be higher. ...
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