Status:
COMPLETED
The Body's Affect on Vitamin C
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
Pharmacokinetics is the term used for how the body affects a drug once it is taken. Vitamin C, also known as ascorbic acid, is an essential water soluble vitamin. Meaning, the body does not make Vitam...
Detailed Description
Vitamin C (ascorbic acid, ascorbate) is an essential water soluble vitamin. Our studies at NIH were the first to demonstrate in healthy men and women how changes in a vitamin concentration in human pl...
Eligibility Criteria
- INCLUSION CRITERIA:
- 10 Males - ages 18 - 35 yrs
- 10 Females - ages 18 - 35 yrs
No more than 4 subjects during any period will remain as inpatients on the endocrine/metabolic ward. These subjects will be normal volunteers selected from colleges/universities who will:
- Spend within a fall or spring semester (approximately 20-26 weeks) as an inpatient resident on the endocrine-metabolic ward at NIH.
- Be willing to adhere to an ascorbate restricted diet for the duration of the time spent in the study as an inpatient at NlH.
- Have veins adequate for venipunctures and be willing to undergo venipunctures approximately two to three times per week.
- Refrain from ingestion of any medication and cigarette smoking and ethanol.
- Be able to give informed consent.
EXCLUSION CRITERIA:
- Subject non-compliance with restricted diet.
- Pregnancy as determined by history, physical exam and urine b-HCG.
- History of diabetes mellitus, bleeding disorders, kidney stones, glucose-6- phosphate dehydrogenase deficiency, family history of hemochromatosis/iron overload.
- Platelet count <150,000/ul blood; prothrombin time/partial thromboplastin time (PT/PTT) > 1 second above normal upper limit.
- Positive test for exposure to human immunodeficiency virus.
- Positive tests for hepatitis B surface antigen, core antibody or surface antibody.
Key Trial Info
Start Date :
January 23 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00001309
Start Date
January 23 1997
End Date
March 4 2019
Last Update
April 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892