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Thiamine in Patients With Clinically Suspected Dry Beriberi

NCT04977557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Dry Beriberi

Interventions

DIETARY_SUPPLEMENT

Thiamine

Injection Thiamine 200 mg daily intravenously for 1 week followed by Tablet Thiamine 100mg bid for remaining 11 weeks

Sponsors & Collaborators

  • Chittagong Medical College

    lead OTHER

Principal Investigators

  • Nayema Masrura, MD,MBBS · Thesis Student

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2019-04-30
Completion
2019-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04977557 on ClinicalTrials.gov