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The Body's Affect on Vitamin C

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 356 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 7 words

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: * 10 Males - ages 18 - 35 yrs * 10 Females - ages 18 - 35 yrs No more than 4 subjects during [...] al volunteers selected from colleges/universities who will: 1. Spend within a fall or spring semester (approximately 20-26 [...] inpatient resident on the endocrine-metabolic ward at NIH. 2. Be willing to adhere to an ascorbate restricted diet for the [...] tion of the time spent in the study as an inpatient at NlH. 3. Have veins adequate for venipunctures and be willing to unde [...] go venipunctures approximately two to three times per week. 4. Refrain from ingestion of any medication and cigarette [...] [...]

  3. Minor

    48 amendments

    48 re-verifications since 2025-02-01, no change to tracked fields

    v307-v354

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....
Trial Details
NCT Number NCT00001309
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Healthy Volunteers
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov