Vitamin e study aims to uncover how body fat affects nutrient needs in women
NCT ID NCT00862433
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 14 times
Summary
This completed Phase 1 study looked at how vitamin E is absorbed and used in the bodies of normal-weight and obese women, and whether vitamin C helps. Fifty women aged 18 to 40 took part, including some with type 2 diabetes. Researchers gave different doses of vitamin E (by mouth and IV) and vitamin C, then measured levels in blood and urine to understand how body fat affects vitamin E needs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin E (deuterated) and Vitamin C
- What this could lead to
- If successful, this study could help determine the right amount of vitamin E women need, especially those with more body fat, and clarify how vitamin C supports vitamin E's role in the body.
- What could go wrong
- This is a small, early-phase study focused on measuring how the body processes vitamins, not on treating or preventing disease. Results may not lead to direct health recommendations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Oct 2014
- Finished
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May 2022
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Subjects to be recruited for the study: * Healthy women * Ages 18 to 40 years old * Able to give informed consent * Blood pressure \<160/90 mm Hg * Nonobese (BMI less than or equal to 29.9) without diabetes * Overweight (BMI greater than or equal to 27) without diabetes * Overweight (BMI greater than or equal to 27) with mild to moderate non-insulin dependent diabetes (Type 2 diabetes) * who are treated with diet alone or submaximal doses of oral hypoglycemic agents * whose fasting blood sugar is \< 200mg/dl or HbA1C \< 7.5 * with no known target organ damage (End organ damage includes the following: proliferative retinopathy, serum creatinine \< 1.8 m/dl, ischemic heart disease, congestive heart failure, peripheral vascular disease and peripheral neuropathy) * No regular medication other than aspirin (other than oral hypoglycemic agents, hormonal contraceptives and medications taken only on an as-needed basis). * Willingness to use effective contraceptive methods for the duration of the study EXCLUSION CRITERIA: Subjects with the following diseases or abnormalities will not be eligible for the study: * Digestive abnormalities, such as malabsorption or chronic diarrhea * Organ malfunction, including (but not limited to) liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease * Hypertension (blood pressure \>160/90) * Anemia (hematocrit \< 30) * Current or history of serious or chronic illness, including hyperlipidemia or hypercholesterolemia * Complications from diabetes such as kidney damage (renal insufficiency, serum creatinine \>1.8), eye damage (proliferative retinopathy), diabetic neuropathy, coronary artery disease, or peripheral vascular disease * Tobacco smoking * Use of medications (other than oral hypoglycemic agents, hormonal contraceptives and medications taken only on an as-needed basis). * Alcohol or drug abuse * Insulin treatment * Pregnancy or lactation (a urine pregnancy test will be performed on all women with reproductive age before each part of the study or monthly as necessary) * Positive HIV or hepatitis (b or c) screening tests * Food allergy, to soy or egg, milk protein (casein), or wheat/gluten * Known coagulopathy * Unwillingness to use effective contraceptive methods such as barrier methods for the duration of the study. Patients on antihypertensive medication are excluded even if blood pressure is well controlled because antihypertensive medication may affect vitamin E status, thus introducing a confounding variable. Whether antihypertensive medication interacts with vitamin E is not known. Patients on insulin treatment are excluded because Insulin treatment indicates a more severe form of diabetes than the mild to moderate type two diabetes that need only dietary treatment or treatment with submaximal doses of oral hypoglycemic agents for adequate blood sugar control. The effect of insulin administration on vitamin E is unknown, and is a confounding factor that will make data interpretation difficult.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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