Dry BeriberiNCT04977557
Thiamine in Patients With Clinically Suspected Dry Beriberi
A study testing Thiamine in people with Dry Beriberi, run by Chittagong Medical College at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Beriberi
- What is being tested?
- Thiamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 Nov 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 )
Show all 10Show fewer
- Absent or reduced deep tendon reflexes
- Positive squat test (unable to rise after squatting without help)
- Leg swelling
- Age 18 years and above.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Thiamine in Patients With Clinically Suspected Dry Beriberi: An Open Labeled Hospital Bases Study in Bangladesh
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.
Read the detailed 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:
- 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 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.
- Conditions
- Dry Beriberi
- Being tested
- Thiamine
- Keywords
- Neuritic beriberi, Dry beriberi, thiamine efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDietary supplement
Injection Thiamine 200 mg daily intravenously for 1 week followed by Tablet Thiamine 100mg bid for remaining 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
Secondary outcomes (9)
change in leg swelling
it may be mild (pitting disappears immediately after removing finger pressure), moderate (requiring less than 30 seconds to disappear after giving pressure), severe (requiring more than 30 seconds to disappear after giving pressure)
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in muscle power
Medical Research Council (MRC) score is used, highest score 5 (Normal Power) and lowest score 0 (No muscle power)
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in muscle cramp
Visual Analogue Scale (VAS) will be used for assessing severity of Muscle cramp. no cramp=0, mild cramp=1 to 3, moderate cramp= 4 to 6, severe cramp =7 to 10.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in deep tendon reflexes
deep tendon reflexes may be Normal , diminished or absent.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in squat test
squat test may be positive (inability or difficulty in raising from sitting position) or negative (no difficulty )
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in pain sensation
Visual Analogue Scale (VAS) will be used for assessing severity of pain. no pain=0, mild pain= 1 to 3, moderate pain= 4 to 6, severe pain= 7 to 10.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in position sensation
it may be Normal , diminished or absent.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in vibration sensation
it may be Normal , diminished or absent.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in touch sensation
it may be Normal , diminished or absent.
Measured: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start11 Nov 2018
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry BeriberiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayema Masrura, Chittagong Medical College
- Investigators
- Nayema Masrura, MD,MBBS, Principal investigator, Thesis Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977557
- Sponsor's protocol ID
- 472
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thiamine in Patients With Clinically Suspected Dry Beriberi: An Open Labeled Hospital Bases Study in Bangladesh
- ClinicalTrials.gov ID
- NCT04977557
- Acronym / sponsor ID
- 472
- Conditions
- Dry Beriberi
- Keywords
- Neuritic beriberi, Dry beriberi, thiamine efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Dietary Supplement: Thiamineits a quasi experimental study where single group is used (self controlled clinical trial). clinical features were compared before iand after intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Any person admitted to CMCH as a Suspected thiamine deficiency related peripheral Neuropathy / Possible dry-beriberi:
- 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.
- Age 18 years and above.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineInjection Thiamine 200 mg daily intravenously for 1 week followed by Tablet Thiamine 100mg bid for remaining 11 weeks | Dietary supplement | single arm |
Primary outcome
change in Overall Neuropathy Limitation Scale (ONLS) score
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
it is score measuring functional status of peripheral neuropathy patients. lowest score is 0 (No disability) and highest score 12 (most disability)
9 secondary outcomes
change in leg swelling
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in muscle power
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in muscle cramp
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in deep tendon reflexes
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in squat test
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in pain sensation
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in position sensation
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in vibration sensation
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
change in touch sensation
Time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayema Masrura, MD,MBBS principal investigator
Thesis Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiamine in people with Dry Beriberi, run by Chittagong Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Overall Neuropathy Limitation Scale (ONLS) score (time frame: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.