How many clinical trials are studying Thiamine?

3 recruiting trials in our tracked data involve Thiamine.

What conditions is Thiamine being studied for?

In our tracked recruiting trials, Thiamine is being studied in trials for ADHD, Attention Deficit Hyperactivity Disorder, Cirrhosis.

Thiamine: clinical trials recruiting now

Q: Is Thiamine FDA-approved?

Yes. According to the FDA drug label available through openFDA, Thiamine is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Thiamine appears in the FDA drug-label database. Marketed as THIAMINE HYDROCHLORIDE injection, solution.

FDA-approved use

Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901. — Mylan Institutional LLC	Class III (FDA: unlikely to cause harm)	Terminated	2021-05-03

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Not applicable 2

Conditions being studied

Condition	Trials
ADHD	1
Attention Deficit Hyperactivity Disorder	1
Cirrhosis	1
Covert Hepatic Encephalopathy	1
Hepatic Encephalopathy	1
Hypertension	1
Sleep Disturbances and Insomnia	1
Type 2 diabetes	1
Type2diabetes	1

Recruiting trials involving Thiamine

Affect of Melatonin on Sleep and Cognition in Cirrhosis
NCT07046429 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
NCT07665658 · Phase: Not applicable (e.g. observational or device study) · Ages: 6 Years to 12 Years · Sex: All (male and female) · 1 location
Type 2 Diabetes and Blood Brain Barrier Improvement
NCT06322212 · Phase: Early Phase 1 · Ages: 40 Years to 65 Years · Sex: All (male and female) · 1 location

Common questions

Is Thiamine FDA-approved?

Yes, marketed as THIAMINE HYDROCHLORIDE injection, solution.

How many recruiting trials involve Thiamine?

3 recruiting trials across 9 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.