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Vitamin C for Type 2 Diabetes

Phase 1
Recruiting
Led By Ifechukwude C Ebenuwa, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage 1: Willingness to use effective contraceptive methods such as barrier method for the duration of study (female subjects)
Blood pressure with or without medication <160/90 mmHg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine >1.5 or EGFR < 55 mL/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights

Study Summary

This trial will investigate whether vitamin C can help prevent microvascular disease in type II diabetes.

Who is the study for?
Adults aged 18-65 with Type 2 Diabetes, having an HgA1C of <=12% and generally in good health can join this trial. They must be on insulin or oral hypoglycemic agents, have controlled blood pressure, and agree to use contraception if female. Those with mild diseases like hypothyroidism may participate. People with severe illnesses, diabetic complications, or a history of non-compliance are excluded.Check my eligibility
What is being tested?
The study is testing whether Vitamin C supplements can improve the flexibility of red blood cells (RBCs) in people with diabetes by reducing microvascular damage. Participants will undergo two hospital stays for monitoring without and then with Vitamin C supplementation to see if there's any change in RBC rigidity related to their glucose levels.See study design
What are the potential side effects?
Vitamin C and E supplements used in this trial are considered safe at the prescribed doses; however, potential side effects could include digestive discomfort or allergic reactions. The risk associated with these vitamins is minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to use effective birth control methods during the study.
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My blood pressure is under control, and I don't have serious heart, kidney, or blood vessel problems.
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My type 2 diabetes is managed and my HgA1C is 12% or lower.
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I am in good health with no major illnesses.
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My blood pressure is under 160/90 mmHg, with or without medication, and I have no significant organ damage.
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I am between 18 and 65 years old and can consent to treatment.
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I have a mild condition like slightly underactive thyroid.
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I have type 2 diabetes with HgA1C <= 12% and am on treatment, or I do not have diabetes.
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My vitamin C levels are above 30 uM before hospital studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whether RBCs have low vitamin C concentrations in patients with poorly controlled diabetes, as measured by Hba1C.
Whether acute changes in glycemia and/or red blood cell ascorbate (vitamin C) modify RBC deformability.
Whether acute glycemic control affects urinary leakage of ascorbate (vitamin C).
+1 more
Secondary outcome measures
Whether RBC deformability is affected by vitamin C supplementation.
Whether RBC vitamin C concentrations can be increased by vitamin Csupplementation over several weeks in diabetic subjects.

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT03148236
10%
Pericarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin C
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stage 2Experimental Treatment1 Intervention
Subjects may be considered for arm stage 2 inpatient study no less than 8 weeks duration from arm stage 1 study. Once the RBC vitamin C concentrations are optimal (>30 uM), subjects may be re-admitted to Clinical Center metabolic unit and undergo the same protocol as described above in arm stage 1. Oral vitamin C and E supplementation may be discontinued on admission. The inpatient diet, glucose monitoring and sampling scheme will be the same as described for the first inpatient study.
Group II: Stage 1Experimental Treatment1 Intervention
Upon admission, diabetic subjects maywill discontinue their oral hypoglycemic medications and/or insulin regimen per investigators discretion. Oral hypoglycemic agents and/or insulin doses will be adjusted and may be supplemented with a correction scale and/or and transitioned to a basal-bolus insulin regimen. In order to achieve optimal glycemic monitoring and for safety reasons, subjects may be fitted with a Dexcom continuous glucose monitor (CGM) upon inpatient admission. CGM will be used to supplement, rather than replace, fingerstick glucose measurements. CGM monitoring will include a sensor fitted subcutaneously, a wireless transmitter that allows for remote glucose monitoring by the research team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C
2017
Completed Phase 4
~18470

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,348 Previous Clinical Trials
4,314,632 Total Patients Enrolled
107 Trials studying Diabetes
138,663 Patients Enrolled for Diabetes
Ifechukwude C Ebenuwa, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
5,000 Total Patients Enrolled
1 Trials studying Diabetes
5,000 Patients Enrolled for Diabetes

Media Library

Vitamin C Clinical Trial Eligibility Overview. Trial Name: NCT02107976 — Phase 1
Diabetes Clinical Trial 2023: Vitamin C Highlights & Side Effects. Trial Name: NCT02107976 — Phase 1
Vitamin C 2023 Treatment Timeline for Medical Study. Trial Name: NCT02107976 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the ambitions of this clinical experiment?

"This clinical trial is estimated to end in the near future and its primary objective is assessing if acute glycemic control impacts ascorbate leakage. Secondary objectives include determining whether vitamin C supplementation over several weeks can increase RBC Vitamin C concentration, exploring any clinically interpretable relationships between quantifiable outcomes and baseline phenotypes such as sex or other factors, and evaluating the effects of vitamin C supplementation on RBC deformability."

Answered by AI

Is the participant registration process open for this trial?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is currently recruiting participants who were initially posted back in June 14th 2019 and was recently updated as of September 17th 2022. 100 research subjects are required from 2 separate sites for enrolment into the study."

Answered by AI

Does the age criteria for this experiment extend beyond twenty years?

"This clinical trial only permits those aged 18 or above and 65 or below to take part, in accordance with the pre-specified inclusion criteria."

Answered by AI

How likely is it to experience adverse effects from Vitamin C consumption?

"The safety of Vitamin C was graded at a 1, as this is a Phase 1 trial with limited evidence supporting its efficacy and the absence of data regarding its safety."

Answered by AI

What criteria must a person fulfill to be eligible for this research project?

"Eligibility criteria for this trial necessitates that patients must have type 2 diabetes and be between 18 to 65 years old. This study seeks to enrol a total of 100 individuals."

Answered by AI

What is the uppermost limit of participants allowed in this clinical experiment?

"Yes, current information on clinicaltrials.gov confirms that the trial is actively seeking participants with a target recruitment of 100 individuals from two distinct medical centres. The study was initiated on June 14th 2019 and most recently updated September 17th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center, 9000 Rockville Pike
What portion of applicants met pre-screening criteria?
Met criteria
~14 spots leftby Dec 2024