CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Vitamin E +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02107976
NCT02107976N/ACompleted

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

National Institutes of Health Clinical Center (CC)·interventional·Posted Apr 9, 2014·Updated May 12, 2026

In Brief

A clinical study evaluating Vitamin E and Vitamin C for Diabetes Type 2. Completed, enrolled 28 participants across 1 site.

Detailed 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 During the two sampling periods, samples will be withdrawn via venous catheter for RBC deformability, vitamin C concentrations and other related research studies.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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Type 2
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartJun 14, 2019
Primary CompletionMar 5, 2025
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.2 years ago

Interventions

Vitamin Edietary

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

Vitamin Cdietary

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