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

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-MEODDY6
Tanggal Input Registry : 18-12-2020

03-11-2020
Pain impact on daily life as measured by Visual Analogue Scale, Numeric Pain Scale, and Brief Pain Inventory measured at baseline, 4 weeks and 8 weeks after initial treatment
- Vitamin D status - Physician global assessment - Patient global assessment - Total symptoms score in painful diabetic neuropathy - Quality of life - Safety profile The secondary outcomes will be measured at baseline, 4 weeks and 8 weeks after initial treatment
 
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial
Eksperimental
This is a randomized clinical trial, active comparator, open label, controlled study. 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)
60
 

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

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
 
129/KEPK-RSB/XII/20
Not Applicable
Not Applicable
05/PZ/XII/2020
Rizaldy Taslim Pinzon