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Protocol Number:
92-DK-0033
- Title:
Pharmacokinetics and Biodistribution of Ascorbic Acid in Healthy Human Subjects
- Number:
92-DK-0033
- 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 Vitamin C it must be taken in through the diet. In this study researchers will attempt to determine how the amount of water consumed affects the level of vitamin C in the blood (specifically the plasma component of the blood).
In this study researchers will take 13 subjects and place them on a Vitamin C restricted diet. Vitamin C levels will be measured twice a week on an outpatient basis until all subjects reach a desired low level of Vitamin C (12-15 micromolar plasma ascorbic acid concentration). Subjects will then be admitted and undergo 24 hour blood and urine collection. Following the collection of samples, subjects will then begin to receive Vitamin C orally (by mouth) and intravenously (injected into the vein). The dosage of Vitamin C will gradually increase from 30 mg-2500 mg divided into two daily doses. Blood and urine samples will be collected each time the dose is increased. The study will take approximately 18 weeks after which the subjects will be discharged in healthy condition.
- Sponsoring Institute:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- Gender:
Male & Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
None
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
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Vitamin C
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Absorption
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Bioavailability
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Pharmacokinetics
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Biodistribution
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Ascorbic Acid
- Recruitment Keyword(s):
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None
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- Condition(s):
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Healthy
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
- None
- Supporting Site:
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National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
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This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
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Clinical manifestations of ascorbic acid deficiency in man
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Metabolism of (14)C and (3)H-labeled 1-ascorbic in human scurvy
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New concepts in the biology and biochemistry of ascorbic acid
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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