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Thiamine for Diabetic Kidney Disease

Phase 4
Waitlist Available
Led By Dr. Gudrun Caspar-Bell, MD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type II diabetes which has been present for at least 5 years
Be between 18 and 65 years old
Must not have
Recipients of renal and/or pancreatic transplant
Women who were pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether thiamine supplements can help reduce inflammation in people with diabetes, which may in turn help reduce kidney and retinal damage.

Who is the study for?
This trial is for people who have had Type II diabetes for at least 5 years, with a specific kidney condition (microalbuminuria), controlled blood sugar levels (HbA1c ≤ 8%), and a BMI between 19-40. It's not open to those with serious other health issues, thiamine allergies or current use, recent trial participants, or women who are pregnant or breastfeeding.
What is being tested?
The study tests if taking Thiamine (Vitamin B1) daily can prevent kidney damage in diabetics by reducing inflammation. Participants will either receive Thiamine or a placebo without knowing which one they're getting to compare the effects fairly.
What are the potential side effects?
Thiamine is generally considered safe and side effects are rare but may include mild reactions like itching or rash. Since it's a vitamin supplement, severe side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type II diabetes for at least 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a kidney and/or pancreas transplant.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thiamine SupplementationExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
255 Previous Clinical Trials
154,402 Total Patients Enrolled
Dr. Gudrun Caspar-Bell, MDPrincipal InvestigatorUniversity of Saskatchewan

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT01725412 — Phase 4
Kidney disease Research Study Groups: Thiamine Supplementation, Placebo
Kidney disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT01725412 — Phase 4
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT01725412 — Phase 4
~3 spots leftby Nov 2025
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