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Search / Trial NCT00001309

Trial Information

Current as of March 20, 2025

Completed

Keywords

Pharmacokinetics Biodistribution Ascorbic Acid

ClinConnect Summary

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 plasma vary as a direct function of the amount ingested, over a wide range. ln the present study, we plan to achieve a prescorbutic vitamin C plasma concentration of approximately 5-10 micromolar in healthy human volunteers. We will gradually replete these subjects with incremental doses of vitamin C to measure how their plasma, red blood cell, and leukocyte concentrations will change as a functi...

Gender

ALL

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:
  • 1. Spend within a fall or spring semester (approximately 20-26 weeks) as an inpatient resident on the endocrine-metabolic ward at NIH.
  • 2. Be willing to adhere to an ascorbate restricted diet for the duration of the time spent in the study as an inpatient at NlH.
  • 3. Have veins adequate for venipunctures and be willing to undergo venipunctures approximately two to three times per week.
  • 4. Refrain from ingestion of any medication and cigarette smoking and ethanol.
  • 5. Be able to give informed consent.
  • EXCLUSION CRITERIA:
  • 1. Subject non-compliance with restricted diet.
  • 2. Pregnancy as determined by history, physical exam and urine b-HCG.
  • 3. History of diabetes mellitus, bleeding disorders, kidney stones, glucose-6- phosphate dehydrogenase deficiency, family history of hemochromatosis/iron overload.
  • 4. Platelet count \<150,000/ul blood; prothrombin time/partial thromboplastin time (PT/PTT) \> 1 second above normal upper limit.
  • 5. Positive test for exposure to human immunodeficiency virus.
  • 6. Positive tests for hepatitis B surface antigen, core antibody or surface antibody.

Trial Officials

Mark A Levine, M.D.

Principal Investigator

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

About National Institute Of Diabetes And Digestive And Kidney Diseases (Niddk)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a prominent research institution within the National Institutes of Health (NIH) dedicated to advancing scientific knowledge and promoting health in the areas of diabetes, endocrine and metabolic disorders, obesity, digestive diseases, and kidney diseases. Through rigorous clinical trials and innovative research initiatives, NIDDK aims to improve prevention, diagnosis, and treatment strategies, ultimately enhancing patient outcomes and quality of life. The institute fosters collaboration among researchers, healthcare professionals, and community stakeholders to drive impactful discoveries and translate findings into effective healthcare solutions.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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