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NCT03717896
Thiamine As Adjunctive Therapy for Diabetic Ketoacidosis
Phase 2 trial testing 200mg IV thiamine in 50mL 0.9% saline in Diabetic Ketoacidosis in 100 participants. Completed in 1 October 2024.
30 September 2024
Quick facts
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 21 November 2018 |
| Primary completion | 30 September 2024 |
| Estimated completion | 1 October 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 200mg IV thiamine in 50mL 0.9% saline — full drug profile →
- Placebo
Conditions studied
- Diabetic Ketoacidosis — all drugs for Diabetic Ketoacidosis →
Sponsor
Beth Israel Deaconess Medical Center
Who can join
18 and older, any sex, with Diabetic Ketoacidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Thiamine as adjunctive therapy for diabetic ketoacidosis (DKAT) trial protocol and statistical analysis plan: a prospective, single-centre, double-blind, randomised, placebo-controlled clinical trial in the USA.
Vine J, Mehta S, Balaji L, Berg KM, et al · · 2024 · cited 3× · PMID 38423765 · DOI 10.1136/bmjopen-2023-077586 -
The Impact of Extended-Hours Patient Recruitment on Critical Care Clinical Trial Enrollment.
Lee JH, Vine J, Meier M, Berkovitz A, et al · · 2025 · PMID 40138529 · DOI 10.1097/cce.0000000000001239 -
Cellular oxygen consumption in patients with diabetic ketoacidosis.
Vine J, Lee JH, Balaji L, Grossestreuer AV, et al · · 2024 · PMID 39497011 · DOI 10.1186/s40635-024-00673-0
Verify or expand the search:
- PubMed search for NCT03717896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Ketoacidosis
Currently open trials in the same condition.
- NCT07167693 — Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes · Phase 1, PHASE2 · recruiting
- NCT07127406 — Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users · active not recruiting
- NCT06955416 — REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis · Phase 2, PHASE3 · recruiting
- NCT07193069 — Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning · recruiting
Other Beth Israel Deaconess Medical Center trials
Trials by the same sponsor.
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- NCT07277244 — Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study · NA · enrolling by invitation
- NCT06896474 — SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03717896 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beth Israel Deaconess Medical Center
- Last refreshed: 31 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03717896.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing