The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
NCT ID: NCT04689971
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2020-11-03
2021-11-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline and vitamin B combination (B1 100 mg, B2 200 mg and B12 200 mcg) tablet once daily (experimental group).
Standard therapy
Gabapentin, pregabalin, or amitriptyline
Vitamin B combination
Vitamin B combination (B1 100 mg, B2 200 mg and B12 200 mcg) tablet once daily
Control Group
Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline.
Standard therapy
Gabapentin, pregabalin, or amitriptyline
Interventions
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Standard therapy
Gabapentin, pregabalin, or amitriptyline
Vitamin B combination
Vitamin B combination (B1 100 mg, B2 200 mg and B12 200 mcg) tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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PT SOHO Global Health Tbk
UNKNOWN
Duta Wacana Christian University
OTHER
Responsible Party
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Rizaldy Taslim Pinzon
Principal investigator, Neurologist
Principal Investigators
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Rizaldy Pinzon, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Duta Wacana Christian University
Locations
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Bethesda Hospital Yogyakarta
Yogyakarta, Special Region of Yogyakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Rizaldy T Pinzon, MD, MSc, PhD
Role: primary
References
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Andres E, Loukili NH, Noel E, Kaltenbach G, Abdelgheni MB, Perrin AE, Noblet-Dick M, Maloisel F, Schlienger JL, Blickle JF. Vitamin B12 (cobalamin) deficiency in elderly patients. CMAJ. 2004 Aug 3;171(3):251-9. doi: 10.1503/cmaj.1031155.
Head KA. Peripheral neuropathy: pathogenic mechanisms and alternative therapies. Altern Med Rev. 2006 Dec;11(4):294-329.
Jayabalan B, Low LL. Vitamin B supplementation for diabetic peripheral neuropathy. Singapore Med J. 2016 Feb;57(2):55-9. doi: 10.11622/smedj.2016027.
Liu KW, Dai LK, Jean W. Metformin-related vitamin B12 deficiency. Age Ageing. 2006 Mar;35(2):200-1. doi: 10.1093/ageing/afj042.
Negrao L, Almeida P, Alcino S, Duro H, Liborio T, Melo Silva U, Figueira R, Goncalves S, Neto Parra L. Effect of the combination of uridine nucleotides, folic acid and vitamin B12 on the clinical expression of peripheral neuropathies. Pain Manag. 2014 May;4(3):191-6. doi: 10.2217/pmt.14.10. Epub 2014 May 16.
Okada K, Tanaka H, Temporin K, Okamoto M, Kuroda Y, Moritomo H, Murase T, Yoshikawa H. Methylcobalamin increases Erk1/2 and Akt activities through the methylation cycle and promotes nerve regeneration in a rat sciatic nerve injury model. Exp Neurol. 2010 Apr;222(2):191-203. doi: 10.1016/j.expneurol.2009.12.017. Epub 2010 Jan 4.
Selvarajah D, Kar D, Khunti K, Davies MJ, Scott AR, Walker J, Tesfaye S. Diabetic peripheral neuropathy: advances in diagnosis and strategies for screening and early intervention. Lancet Diabetes Endocrinol. 2019 Dec;7(12):938-948. doi: 10.1016/S2213-8587(19)30081-6. Epub 2019 Oct 14.
Sun Y, Lai MS, Lu CJ. Effectiveness of vitamin B12 on diabetic neuropathy: systematic review of clinical controlled trials. Acta Neurol Taiwan. 2005 Jun;14(2):48-54.
Tesfaye S, Boulton AJ, Dickenson AH. Mechanisms and management of diabetic painful distal symmetrical polyneuropathy. Diabetes Care. 2013 Sep;36(9):2456-65. doi: 10.2337/dc12-1964.
Ting RZ, Szeto CC, Chan MH, Ma KK, Chow KM. Risk factors of vitamin B(12) deficiency in patients receiving metformin. Arch Intern Med. 2006 Oct 9;166(18):1975-9. doi: 10.1001/archinte.166.18.1975.
Other Identifiers
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SOHOBION
Identifier Type: -
Identifier Source: org_study_id