In vivo location of sulbutiamine conversion to thiamine Vers 0.1
Research type
Research Study
Full title
In vivo location of sulbutiamine conversion to thiamine
IRAS ID
266457
Contact name
Michael Eddleston
Contact email
Sponsor organisation
NHS Lothian
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Thiamine deficiency is common, causing brain injury in alcoholics and exacerbating heart failure. Prevention requires prophylaxis with thiamine. However, the thiamine hydrochloride currently used has poor oral absorption, necessitating parenteral administration for effective supplementation as per SIGN guidelines. However, community compliance is low and deficiency remains a problem. A thiamine formulation with high oral bioavailability for community use is required to prevent thiamine deficiency and its complications. We have shown that lipid-soluble ‘allithiamines’ (eg. sulbutiamine) are well absorbed and converted to thiamine after oral administration. We now aim to locate where sulbutiamine is converted to thiamine. We hypothesise that this will occur in the wall of the intestine, before being absorbed into the blood stream.
In this study, we will recruit ten patients with chronic liver disease who have had a shunt placed across the liver to treat high blood pressure in the portal vein. Every six months, patients routinely come to clinic for a doctor to test that the shunt is still working and patent. To do this, a tube is placed into a vein in the groin by a radiology doctor and passed through the liver to the hepatic portal vein where some dye is injected to show it is working. The participants will be administered sulbutiamine 200mg tablets just before or after placement of the catheter. Once the catheter is placed correctly, a 2 mL blood sample each will be taken at 10, 15, 20, 25 and 30 min after sulbutiamine ingestion. A further five mL of blood will be collected from an indwelling peripheral venous cannula at 10 and 30 min. We will check the amount of thiamine and sulbutiamine in the sample.
A relatively high concentration of thiamine compared to sulbutiamine would support the hypothesis that conversion occurs before passing into the blood.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0123
Date of REC Opinion
22 Jun 2021
REC opinion
Further Information Favourable Opinion