The Body's Affect on Vitamin C

NCT00001309 | Completed Phase 1

• 2 other identifiers: 92003392-DK-0033
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Biodistribution; Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

• Changes in ascorbic acid concentrations

  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).

  5 years

Study Arms (1)

Pharmacokinetics and Biodistribution of Ascorbic Acid

OTHER

Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.

Other: Vitamin C

Interventions

Vitamin C OTHER

Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.

Pharmacokinetics and Biodistribution of Ascorbic Acid

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males - ages 18 - 35 yrs
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Mark A Levine, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: January 23, 1997
• Primary Completion: August 25, 1999
• Study Completion: March 4, 2019
• Last Updated: May 1, 2026

Record last verified: 2026-01-21

Locations

US (1)