The Body's Affect on Vitamin C

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

January 23, 1997

Primary Completion Date

August 25, 1999

Study Completion Date

March 4, 2019

Conditions
Healthy Volunteers
Interventions
OTHER

Vitamin C

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

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

NIH

NCT00001309 - The Body's Affect on Vitamin C | Biotech Hunter | Biotech Hunter