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

Duta Wacana Christian University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Vitamin D 5,000IU Oral Tablet; Drug: Standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04689958

VITAMIND5000IU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Drug: Vitamin D 5,000IU Oral Tablet

Drug: Standard therapy

Control Group

Active Comparator group

Description:

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline

Treatment:

Drug: Standard therapy