Status:
UNKNOWN
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
Lead Sponsor:
Duta Wacana Christian University
Collaborating Sponsors:
PT SOHO Global Health Tbk
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
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 diabeti...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04689958
Start Date
November 3 2020
End Date
November 1 2021
Last Update
December 30 2020
Active Locations (1)
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1
Bethesda Hospital Yogyakarta
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55224