The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

Sponsor

Duta Wacana Christian University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04689958

Collaborator

PT SOHO Global Health Tbk (Other)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy	Drug: Standard therapy Drug: Vitamin D 5,000IU Oral Tablet	Phase 2/Phase 3

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Masking Description:

Open label

Primary Purpose:

Treatment

Official Title:

The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial

Actual Study Start Date :

Nov 3, 2020

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline and vitamin D 5000 IU once daily (experimental group).	Drug: Standard therapy Gabapentin, pregabalin, or amitriptyline Drug: Vitamin D 5,000IU Oral Tablet Vitamin D 5000 IU oral tablet once daily
Active Comparator: Control Group Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline	Drug: Standard therapy Gabapentin, pregabalin, or amitriptyline

Arm

Intervention/Treatment

Experimental: Experimental Group

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline and vitamin D 5000 IU once daily (experimental group).

Drug: Standard therapy

Gabapentin, pregabalin, or amitriptyline

Drug: Vitamin D 5,000IU Oral Tablet

Vitamin D 5000 IU oral tablet once daily

Active Comparator: Control Group

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline

Drug: Standard therapy

Gabapentin, pregabalin, or amitriptyline

Outcome Measures

Primary Outcome Measures

Improvement in Visual Analogue Scale (VAS) at week 4 [4 weeks after treatment initiation]
Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Improvement in Visual Analogue Scale (VAS) at week 8 [8 weeks after treatment initiation]
Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline and week 4 value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Improvement in Numeric Pain Scale at week 4 [4 weeks after treatment initiation]
Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.
Improvement in Numeric Pain Scale at week 8 [8 weeks after treatment initiation]
Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline and week 4 value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.
Improvement in Brief Pain inventory at week 4 [4 weeks after treatment initiation]
Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.
Improvement in Brief Pain inventory at week 8 [8 weeks after treatment initiation]
Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline and week 4 value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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