Thiamine in Patients With Clinically Suspected Dry Beriberi

NCT04977557 | Completed

• 1 other identifier: 472
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neuritic beriberi; Dry beriberi; thiamine efficacy

Outcome Measures

Primary Outcomes (1)

• change in Overall Neuropathy Limitation Scale (ONLS) score

  it is score measuring functional status of peripheral neuropathy patients. lowest score is 0 (No disability) and highest score 12 (most disability)

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

Secondary Outcomes (9)

• change in leg swelling

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

• change in muscle power

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

• change in muscle cramp

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

• change in deep tendon reflexes

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

• change in squat test

  before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment

Study Arms (1)

single arm

OTHER

its a quasi experimental study where single group is used (self controlled clinical trial). clinical features were compared before iand after intervention

Dietary Supplement: Thiamine

Interventions

Thiamine DIETARY_SUPPLEMENT

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

single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any person admitted to CMCH as a Suspected thiamine deficiency related peripheral Neuropathy / Possible dry-beriberi:
• Risk factors + at least 2 of the following signs:
• Risk factors include Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, Gastrointestinal surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic. diuretics use, renal dialysis, total parenteral nutrition.
• Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale)
• Positive sensory symptoms (burning, tingling or pain)
• Objective sensory deficit (pain, touch, position, vibration sense )
• Absent or reduced deep tendon reflexes
• Positive squat test (unable to rise after squatting without help)
• Leg swelling
• Age 18 years and above.

You may not qualify if:

• Patients with isolated cardiac/wet beriberi.
• Patient with known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), drugs (e.g. Isoniazid, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) Toxin (As ,Organo-phosphate Compound (OPC), Pb ,Hg except alcohol) etc.
• Patients refuse to participate.

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, 4203, Bangladesh

Location

MeSH Terms

Interventions

Thiamine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Nayema Masrura, MD,MBBS

  Thesis Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thesis Student, Department of Neurology

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 27, 2021
• Study Start: November 11, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

BA (1)