CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled / 102 target
Drug / intervention
200mg IV thiamine in 50mL 0.9% saline +1 moredrug
Likely dose
200mg IV thiamine in 50mL 0.9% salinefrom 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/NCT03717896
NCT03717896Phase 2CompletedOn Track (1.1/mo)Completion was 21mo ago
CompareCT.gov

Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis

Beth Israel Deaconess Medical Center·interventional·Posted Oct 24, 2018·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating 200mg IV thiamine in 50mL 0.9% saline and Placebo for Diabetic Ketoacidosis. Completed, enrolled 102 participants across 1 site.

Detailed Summary

This is a randomized, double-blind, placebo-controlled trial to determine if administration of intravenous thiamine will lead to quicker resolution of acidosis in patients admitted to the hospital with diabetic ketoacidosis. The investigators will secondarily investigate whether thiamine improves cellular oxygen consumption, shortens intensive care unit (ICU) and hospital stay or decreases hospital resource utilization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Ketoacidosis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartNov 21, 2018
Primary CompletionSep 30, 2024
Study CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 7.7 years ago

Arms & Interventions

Thiamineexperimental

200mg IV thiamine in 50mL 0.9% saline twice daily for 2 days

Drug: 200mg IV thiamine in 50mL 0.9% saline
Placeboplacebo_comparator

100mL 0.9% saline twice daily for two days

Drug: Placebo

Interventions

200mg IV thiamine in 50mL 0.9% salinedrug

Thiamine 200mg IV every 12 hours for 2 days

Placebodrug

50mL 0.9% saline