Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04977557 |
| Other study ID # |
472 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 11, 2018 |
| Est. completion date |
June 30, 2019 |
Study information
| Verified date |
July 2021 |
| Source |
Chittagong Medical College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This Self-controlled Clinical Trial will be conducted in Department of Neurology and
Department of Medicine of Chittagong Medical College Hospital (CMCH) during July 2018 to June
2019. A total of 55 patients of possible beriberi will be included based on inclusion
criteria. Patients with isolated cardiac/wet beriberi and with other known causes of
peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic
(hepatic/renal impairment), history of intake of drugs (e.g. INH, Ethambutol, Phenytoin,
Metronidazole, Dapsone etc.) and toxins exposure (As ,Organo-phosphate Compound, Pb ,Hg
except alcohol) were excluded from study.
Operational Definitions:
Risk factors: Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine
factors), malnutrition, alcoholism, Gastro-Intestinal surgery, chronic diarrhoea, chronic
vomiting, pregnancy or history of recent delivery, chronic, diuretics use, renal dialysis,
total parenteral nutrition.
Possible/suspected neuritic (dry) beriberi: Risk factors + at least 2 of the following signs:
1. Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale)
2. Positive sensory symptoms (burning, tingling or pain)
3. Objective sensory deficit (pain, touch, position, vibration sense )
4. Absent or reduced deep tendon reflexes
5. Positive squat test (unable to rise after squatting without help)
6. Leg swelling Probable neuritic (dry) beriberi: Above symptoms recovered after thiamine
treatment.
Data collection Procedure: After selection of subjects, detailed history, clinical
examination and all other Information regarding sociodemographic and clinical factors of
neuritic beriberi will be taken in a prescribed case record form. Relevant investigations
(CBC, Peripheral Blood Flim (PBF), Serum creatinine, serum electrolytes, Liver function test,
fasting & 2 hour after breakfast sugar. HbA1C, TSH, serum Vitamin B12, Chest X ray, ECG,
Echocardiography, CSF study, Nerve Conduction Study will be performed to exclude differential
diagnoses. Then therapeutic trial of Inj. Thiamine will be given IV for 1st week (200mg IV
daily) then orally (tab. Thiamin 100mg bd) for 11 weeks. Patients will be followed up after
1, 6 and 12 week to see the response on the basis of some clinical parameters and Overall
Neuropathy Limitations Scale (ONLS) score.
Statistical Analysis: Continuous data will be reported as the means ± SD or median and
interquartile range. Qualitative or categorical data will be described as frequencies and
proportions. The intention to treat analysis (ITT) analysis will be used to determine the
statistical significance. Missing values will be replaced by the series means for this
purpose. To determine whether any of the difference between pretreatment and post treatment
values are statistically significant or not, either Friedman's test or Cochran's Q test will
be used. Former test compares the quantitative variables and non-dichotomous qualitative
variables and the later test compares the dichotomous qualitative/categorical variables.
Statistical significance will be defined as P < 0.05 and confidence interval will be set at
95% level.
Variables under study:
Primary Outcome Variable: Treatment response will be measured by Overall Neuropathy
Limitation Scale (ONLS) score before and after treatment.
Secondary Outcome Variables: Comparison and Assessment of clinical features at presentation
and after treatment: leg swelling, muscle cramp, muscle power (MRC grading), deep tendon
reflexes, sensory impairments (tingling /burning /pain/ touch/ position /vibration), squat
test.
This study has received approval from Ethical Review Committee of Chittagong Medical College
and written informed concent.will be taken from all participants.
