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Beriberi clinical trials

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NCT ID: NCT05663164 Completed - Sepsis Clinical Trials

Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This research is a clinical trial with a Randomized Controlled Trial (RCT) design. The purpose is to identify the effect of intravenous thiamine administration compared to normal saline placebo on glucagon levels and ROS levels in patients undergoing general anesthesia surgery

NCT ID: NCT05390086 Completed - Thiamine Deficiency Clinical Trials

Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders

Start date: June 15, 2022
Phase:
Study type: Observational

Thiamine deficiency, including the most severe form infantile beriberi, is a public health concern across South and Southeast Asia, where monotonous diets rely on thiamine-poor white rice. Food insecurity, food preparation and cooking practices, anti-thiamine compound consumption and culturally determined postpartum food restrictions precipitate thiamine deficiency in these high-risk regions. The risk of thiamine deficiency is highest in the first year of life, especially among exclusively or predominantly breastfed infants of mothers who are thiamine deficient themselves, as thiamine content of breastmilk is related to maternal thiamine status. However, diagnosis of infantile thiamine deficiency is challenging due to the highly variable, non-specific clinical manifestations, referred to as thiamine deficiency disorders (TDD), that often overlap with other conditions, resulting in misdiagnosis and missed treatment opportunities, which can be fatal or have irreversible consequences. Considering that breastfed infants are at highest risk, a large proportion of infant deaths could be avoided if: 1) infants with TDD were immediately treated with thiamine when medically indicated and, importantly; 2) thiamine deficiency was prevented by improving thiamine status among breastfeeding women. The latter is important given emerging evidence of long-term neurocognitive deficits of severe and even subclinical thiamine deficiency. In light of these diagnostic uncertainties, it was recognised that a case definition for thiamine responsive disorders (TRD) would help to better identify infants with TDD who would benefit from timely thiamine treatment. This study will test the usefulness of a recently developed case definition for TRD and practical tool in different contexts in Lao PDR where TDD have been reported. Secondly, data on diet, maternal and household risk factors for TDD in different contexts will be used to propose a community risk factor screening tool to better identify populations at risk of thiamine deficiency and help advocate for and guide planning of preventive programmes.

NCT ID: NCT04977557 Completed - Dry Beriberi Clinical Trials

Thiamine in Patients With Clinically Suspected Dry Beriberi

Start date: November 11, 2018
Phase: N/A
Study type: Interventional

Abstract Background: Thiamine deficiency related disorders are increasingly being reported in countries where polished rice is the main dietary constituents and diet is not balanced in calorie, protein and micronutrients contents. Thiamine deficiency often associated with a sensory-motor neuropathy (dry beriberi) without Wernicke's encephalopathy and cardiac dysfunction. Objectives: The objective of our study will be to evaluate the efficacy of thiamine in patients with clinically suspected dry beriberi. Methods: This study will be a prospective, open labeled, self-controlled clinical trial (quasi-experimental study) carried out in the Neurology and Medicine Ward of Chittagong Medical College Hospital from July 2018 to June 2019. Fifty-five (55) patients of suspected dry beriberi will be recruited as per inclusion and exclusion criteria. All patients will be given 200mg IV Thiamine Hydrochloride per day for 1 week, then oral Tab. Thiamine 100mg twice daily for remaining 11week. They will be evaluated clinically before treatment and followed up at the end of 1 week, 6 week and 12 week after treatment. Assessment will be done by some clinical parameters like leg swelling, muscle cramp, muscle power, squat test, sensory impairments, deep tendon reflexes and by Overall Neuropathy Limitations Scale (ONLS) Score. Pre and post test treatment data will be recorded in a pre-designed case record form. To determine whether any o the difference between pretreatment and post treatment values were statistically significant or not, either Friedman's test or Cochran's Q test will be used. Analysis will be performed with SPSS windows version 23 and statistical significance will be defined as P<0.05 and confidence interval will be set at 95% level. Our study result is likely to sensitize the health professionals of this region about this neglected health issue by increasing awareness of the clinical spectrum of Thiamine Deficiency related Peripheral Neuropathy.

NCT ID: NCT04641104 Completed - Thiamine Deficiency Clinical Trials

The Thiamine Administration After Cardiac Surgery Trial

TAACS
Start date: November 20, 2020
Phase: Phase 4
Study type: Interventional

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose. We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

NCT ID: NCT03746106 Completed - Thiamine Deficiency Clinical Trials

The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

Start date: January 28, 2019
Phase: Phase 4
Study type: Interventional

In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin together affects the body's ability to absorb, distribute, and eliminate thiamine (Vitamin B1).

NCT ID: NCT03626337 Completed - Thiamine Deficiency Clinical Trials

Thiamine Responsive Disorders (TRD) Among Infants in Lao PDR

Start date: June 17, 2019
Phase:
Study type: Observational

A hospital- and community-based study in Luang Prabang, Lao PDR, which will include a group of hospitalized children 21 days to <18 months of age who are diagnosed with symptoms compatible with thiamine deficiency disorder (TDD). Based on the infants' response to thiamine administration, children will be defined as either thiamine responsive disorder (TRD) cases or non-responders. A community-based comparison group of infants in the same age range will be included in the study to serve as a control group for identification of potential risk factors.

NCT ID: NCT03616288 Completed - Thiamine Deficiency Clinical Trials

Trial of Thiamine Supplementation in Cambodia

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in thiamine produce thiamine-poor milk, putting their infants at a high risk of developing thiamine deficiency and beriberi. There is also a growing body of evidence suggesting thiamine deficiency not severe enough to cause clinical symptoms may negatively effect cognitive development and functioning of the infant. Since human milk should be the sole source of nutrition for babies during the first six months, maternal thiamine intake must be improved to combat this disease. The investigators' recent study of thiamine-fortified fish sauce in Cambodia showed that fortification could increase maternal and infant thiamine status'. However, centrally produced fish sauce may not reach the poorest communities who make their own fish sauce, and fish sauce is not consumed in all regions where we find thiamine deficiency. Salt, by contrast, is a common condiment in most regions of the world and has proven to be a successful global fortification vehicle for iodine. Suboptimal maternal thiamine intake puts exclusively breastfed infants at risk of low thiamine status, impaired cognitive development, and infantile beriberi, which can be fatal. Thiamine fortification of salt is a potentially low-cost and sustainable means of combating suboptimal thiamine status; however knowledge gaps must be filled before thiamine fortification can proceed. In this study, mothers will consume thiamine supplements in order to model the thiamine dose required to optimize human milk thiamine concentrations for the prevention of beriberi. Other thiamine biomarkers will be assessed, and usual salt intake will be measured. Finally, the investigators will assess the effects of early-life thiamine exposure on infant neuro-cognitive development.

NCT ID: NCT03554668 Completed - Inflammation Clinical Trials

Systemic Inflammatory Response: Thiamine and Magnesium Status (Sir TaM Study)

SirTaM
Start date: January 15, 2018
Phase:
Study type: Observational

We wish to determine to what extent magnesium, thiamine and transketolase activity are affected by the Systemic Inflammatory Response (SIR). The knee arthroplasty model affords the ideal study design, as surgery generates an inflammatory response. Blood samples are drawn preoperatively and for up to four days post operatively, and again at three months post-operation.

NCT ID: NCT03550794 Completed - Sepsis Clinical Trials

Thiamine as a Renal Protective Agent in Septic Shock

Start date: September 4, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.

NCT ID: NCT03466528 Completed - Alcohol Withdrawal Clinical Trials

Alcohol: Thiamine and or Magnesium 1

AToM1
Start date: December 16, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE). Intravenous (IV) thiamine replacement is standard practice in the treatment of alcoholic patients presenting to the Accident & Emergency (A&E) department, however routine co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme transketolase in red blood cells, is not routine practice in the treatment of these patients. Without correction of concomitant magnesium deficiency there may be impaired utilisation of thiamine resulting in a failure to treat WE. This study is designed to determine if administration of magnesium to AUD patients affects red cell transketolasae and serum lactate concentrations by itself, or only acts to increase the effect of thiamine on the activity of this enzyme.