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COMPLETED
NCT02107976
NA

Famine From Feast: Linking Vitamin C, Red Blood Cell Fragility, and Diabetes

Sponsor: National Institutes of Health Clinical Center (CC)

View on ClinicalTrials.gov

Summary

An unexpected means to prevent microvascular disease in diabetes may be coupled to the function of vitamin C in red blood cells (RBCs) of diabetic participants. Based on new and emerging data, vitamin C concentrations in RBCs may be inversely related to glucose concentrations found in diabetes. In this protocol, we will investigate physiology of vitamin C in RBCs of diabetic participants as a function of glycemia, without vitamin C supplementation (baseline) and with vitamin C supplementation (8-week follow-up). As inpatients, participants will have two venous sampling periods each of approximately 24 hours. Insulin doses will be clinically determined and titrated to achieve euglycemia (fasting and pre-meal glucoses \<140mg/dl) prior to the first sampling period (euglycemic sampling). During the two sampling periods, samples will be withdrawn via venous catheter for RBC deformability, vitamin C concentrations and other related research studies. Following baseline measurements, participants will be provided a prescription for vitamin C 500mg twice daily. Given that vitamin C and vitamin E are related antioxidants, and that both vitamins appear to be associated with RBC rigidity, diabetic participants may also be given a prescription for 400 international units (IU) of vitamin E (RRR alpha tocopherol) daily. Participants will continue vitamin C and E supplementation for a minimum of 8 weeks depending on RBC vitamin C concentrations. To evaluate any effect of vitamin E supplementation, plasma and RBC vitamin E levels may be measured concurrently with vitamin C levels, after baseline. All participants will be seen as outpatients at biweekly or monthly intervals with regular measurement of plasma and RBC vitamin C concentrations. Vitamins C and E supplementation will be discontinued upon inpatient admission at the 8-week follow-up period. Risk of both vitamin supplements are minimal as both supplementation doses are safe. Outcomes are to measure RBC rigidity and vitamin concentrations before and after supplementation. In this manner, each participant serves as his/her own control, and deformability of red blood cells can be determined in relation to glycemia and to vitamin C concentrations in RBCs and plasma.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2019-06-14

Completion Date

2025-03-05

Last Updated

2026-05-12

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin E

400 IU per day after discharge, for a minimum of 8 weeks after baseline

DIETARY_SUPPLEMENT

Vitamin C

500mg twice a day after discharge, for a minimum of 8 weeks after baseline

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States