Overview
Vitamin D Treatment for Painful Diabetic Neuropathy
Status:
Completed
Completed
Trial end date:
2013-06-01
2013-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The main objective of the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan. This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D. All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to participate in the study. The change in painful diabetic neuropathy scores was assessed using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each visit.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Baqai Institute of Diabetology and EndocrinologyTreatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:- All patients with type 1 or type 2 diabetes aged 18 to 80 years
- Patient has a diagnosis of painful diabetic neuropathy and reports symmetrical painful
symptoms in distal extremities for a period of 1-5 years prior to the study, and
symptoms were attributable to DPN
- HbA1c level ≤ 11% at the screening visit were considered eligible to participate in
the study.
Exclusion Criteria:
- Patients with renal impairment or hypo or hyperthyroidism,
- Patients currently taking vitamin D supplementation or anti - epileptic or anti -
tuberculosis medication,
- Patients with a previous or current history of primary or tertiary
hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency,
Hepatitis B or C, HIV infection and peripheral neuropathy due to a non-diabetic cause
- Pregnant or breast feeding female patients
- Patients allergic to nuts or any nut products and patients participating in any other
interventional research trial were excluded from the study.