Clinical trial NCT04689958: The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
Official title: The Benefits of Vitamin D 5000 IU 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 D
Standard therapy
Neuropathy
Diabetic 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 D 5000 IU tablet once daily (experimental group).
Primary purpose: TREATMENT

Brief summary: Diabetic neuropathy is one of the micro-vascular complications of diabetes, 30-50% occurring in all diabetic patients. This complication is one of the major cause of morbidity and mortality in diabetic patientsand leading to a deterioration of their quality life. A deficiency of vitamin D \[25-hydroxyvitamin D, 25(OH) D\] is common in patient with diabetes and low concentrations are associated with the presence and severity of sensory neuropathy in diabetes. Vitamin D deficiency has been shown to be an independent risk factor for diabetic peripheral neuropathy (DPN). Topical and oral vitamin D have been reported significantly reduce the symptoms and the pain of DPN. However, no case control clinical trial have been reported that demonstrate the efficacy of vitamin D supplementation on the symptoms of DPN.

Painful in diabetic neuropathy is a major complication of diabetes, characterized by pain, tingling, burning and cramps in the lower legs and feet with a signification reduction in quality of life. Recently, there shown a significant reduction in the severity of painful diabetic neuropathy after treatment with vitamin D. Patient with diabetes have a poor quality of life compared to person without diabetes. The current study assessed the benefits of add on oral vitamin D 5000 IU on diabetic neuropathy patient to pain impact in daily life.

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 D 5000 IU 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 D 5000 IU 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)
* Low vitamin D status of \<30 ng/ml

Exclusion Criteria:

* Subjects with significant renal and liver problem
* Subjects with known hypersensitivity to vitamin D 5000 IU
* 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 T Pinzon, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Basit A, Basit KA, Fawwad A, Shaheen F, Fatima N, Petropoulos IN, Alam U, Malik RA. Vitamin D for the treatment of painful diabetic neuropathy. BMJ Open Diabetes Res Care. 2016 Feb 10;4(1):e000148. doi: 10.1136/bmjdrc-2015-000148. eCollection 2016.
citation: Alam U, Fawwad A, Shaheen F, Tahir B, Basit A, Malik RA. Improvement in Neuropathy Specific Quality of Life in Patients with Diabetes after Vitamin D Supplementation. J Diabetes Res. 2017;2017:7928083. doi: 10.1155/2017/7928083. Epub 2017 Dec 28.
citation: Pinzon RT, Wijaya VO, Veronica V. The Benefits of Add-on Therapy of Vitamin D 5000 IU to the Vitamin D Levels and Symptoms in Diabetic Neuropathy Patients: A Randomized Clinical Trial. J Pain Res. 2021 Dec 19;14:3865-3875. doi: 10.2147/JPR.S341862. eCollection 2021.