Clinical trial NCT04689971: The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
Official title: The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Vitamin B combination
B vitamins
Standard therapy
Diabetic neuropathy
Neuropathy
Lead sponsor: Duta Wacana Christian University
Sponsor class: OTHER
Collaborators: name: PT SOHO Global Health Tbk
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin B combination (vitamin B1 100 mg, B6 200 mg and B12 200 mcg) tablet once daily (experimental group).
Primary purpose: TREATMENT

Brief summary: Large population-based study has shown that the prevalence of painful diabetic neuropathy (PDN) is around 21%, and painful symptoms are more prevalent in patients with type 2 diabetes, females, and Asians. PDN is characterized by symmetrical lower limb paresthesiae, dysesthesiae, lancinating pains and allodynia, with nocturnal exacerbation. PDN cause sleep disturbance and reduce quality of life. The international guidelines advocate a range of therapies for symptom relief. The therapeutic efficacy for all recommended medications is at best around 50% pain relief and is limited due to unwanted side effects. Apart from peripheral and central alterations, metabolic alterations such as increased glycemic influx, and elevated plasma methylglyoxal levels have been implicated in the pathogenesis of PDN.

Several treatment options for PN are available, including pharmacological, non-pharmacological, and alternative options. Patients suffering from severe and disabling symptoms (e.g. NeP) may require guideline treatments like pregabalin, duloxetine, or gabapentin initially until the symptoms are under control. These medications can symptomatically relieve NeP; however, they do not address the underlying cause. Other options such as neurotropic B vitamins (B1, B6, and B12) do not only target the symptoms, but also improve nerve health and contribute to nerve regeneration. The B vitamins are commonly used for PN treatment in clinical practice worldwide, this treatment option is most suitable before the patient suffers from chronic NeP. However, co-treatment with neurotropic B vitamins is also appropriate in NeP patients, to ensure the restoration of nerve health.

Detailed description: This was randomized clinical trial, active comparator, open label, controlled study from the period of November 2020 - November 2021 at Bethesda Hospital, Yogyakarta, Indonesia.

There were 60 painful diabetic neuropathy patients who fulfilled the inclusion and exclusion criteria. Each subject had been followed up from the first day of medication administration until 8 weeks after medication administration.

Ethical approval number ((kosong)) was obtained from Health Research Ethics Committee, Bethesda Hospital Yogyakarta.

The hypothesis of this study:

a. Add on oral vitamin B combination (B1, B6, and B12) to standard treatment in patients with painful diabetic neuropathy is more effective in reducing pain and neuropathic symptoms in 8 weeks of treatment compared with standard treatment, b. Add on oral vitamin B combination (B1, B6, and B12) to standard treatment in patients with painful diabetic neuropathy is as safe as standard treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Adult age (\>18 years old)
* Diagnosed as painful diabetic neuropathy based on validated Diabetic Neuropathy Symptoms (DNS) and Diabetic Neuropathy Examination (DNE)

Exclusion Criteria:

* Subjects with significant renal and liver problem
* Subjects with known hypersensitivity to vitamin B combination
* Pregnancy and breastfeeding patients
* Patients that enrolled any clinical trial within a month
* Not competent enough in giving approval and answering questionnaires

Primary outcomes:
measure: Improvement in Visual Analogue Scale (VAS) at week 4
timeFrame: 4 weeks after treatment initiation
measure: Improvement in Visual Analogue Scale (VAS) at week 8
timeFrame: 8 weeks after treatment initiation
measure: Improvement in Numeric Pain Scale at week 4
timeFrame: 4 weeks after treatment initiation
measure: Improvement in Numeric Pain Scale at week 8
timeFrame: 8 weeks after treatment initiation
measure: Improvement in Brief Pain inventory at week 4
timeFrame: 4 weeks after treatment initiation
measure: Improvement in Brief Pain inventory at week 8
timeFrame: 8 weeks after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Bethesda Hospital Yogyakarta
state: Special Region Of Yogyakarta
Study officials:
affiliation: Duta Wacana Christian University
name: Rizaldy Pinzon, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
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