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Could a simple vitamin speed recovery from a dangerous diabetes complication?

NCT ID NCT03717896

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether giving intravenous thiamine (vitamin B1) alongside standard treatment helps people with diabetic ketoacidosis recover faster. Diabetic ketoacidosis is a serious condition where the blood becomes too acidic. The study includes adults hospitalized with this condition and compares thiamine to a placebo. Researchers will measure how quickly acidosis resolves and whether hospital stays are shortened.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thiamine (vitamin B1)
What this could lead to
If it works, this could speed up recovery from diabetic ketoacidosis and reduce hospital stays.
What could go wrong
This is a small Phase 2 trial, so results may not be conclusive. Thiamine is generally safe, but it may not provide added benefit over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Nov 2018

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Bicarbonate ≤15 mEq/L * Anion gap \> 12 mEq/L * Blood pH≤ 7.24 (if already obtained by clinical team) * Urine ketones (qualitative) or serum ketones (β-hydroxybutyric acid) \> 3 mmol/L * Enrollment within 6 hours of presentation Exclusion Criteria: * Current thiamine supplementation ≥ 6 milligrams per day (i.e., more than a multivitamin) * Competing causes of severe acidosis including seizure, carbon monoxide poisoning, cyanide toxicity, cardiac arrest, liver dysfunction (specifically defined as known cirrhosis) * Known allergy to thiamine * Competing indication for thiamine administration as judged by the clinical team (e.g., significant alcohol use) * Research-protected populations (pregnant women and prisoners) * Patient enrolled previously in same study * Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)

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Conditions

The condition(s) this trial relates to.

Acidosis diabetic ketoacidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic ketoacidosis

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.