Effect of vitamin D3 in the treatment of patients with diabetic neuropathy

Phase 2

Conditions: diabetic nephropathy.
With renal complications Diabetic nephropathy

Registration Number: IRCT201511173140N15

Lead Sponsor: Vice chancellor for research, Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

aged between 20 to 50 years; have type 2 diabetes; control blood glucose less than 140 mg / dl; With BMI 20-35; stage 3 nad 4 diabetic nephropathy; albuminuria more than 30 mg per day; lack of proven vitamin D levels over 15 ng / l and less than 30 ng / l; Do not use calcium supplements and vitamin D in the last 3 months; Not taking medications that affect vitamin D metabolism, such as parathyroid hormone, estrogen, and calcitonin; willingness to cooperate
Exclusion criteria:
Changing the dose of the blood glucose lowering drugs; Change of medication or other treatment; taking calcium and vitamin D supplements during the study; with glomerulonephritis; Phosphorus more than 2/5 mg / dl; corrected calcium more than 10 mg / dl; active malignancy; The possibility of requiring renal replacement over the next year; uncontrolled high blood pressure; Taking antacids containing magnesium; Thiazide diuretics consumption; unwillingness to participate or to continue working

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Albuminuria. Timepoint: Before and after intervention (8 weeks). Method of measurement: Measurement of Albumin in urin by using kits.;Fasting blood glucose. Timepoint: Before and after intervention (8 weeks). Method of measurement: Measurement of fasting blood glucose by using kits.;Hemoglobin A1c. Timepoint: Before and after intervention (8 weeks). Method of measurement: Using ion exchange chromatography.;Insulin. Timepoint: Before and after intervention (8 weeks). Method of measurement: Elisa.;TNF-a. Timepoint: Before and after intervention (8 weeks). Method of measurement: Elisa.;Interlukin6. Timepoint: Before and after intervention (8 weeks). Method of measurement: Elisa.;Added at 2016-02-16: Catalase activity. Timepoint: Added at 2016-02-16: Before and after intervention (8 weeks). Method of measurement: Added at 2016-02-16: AEBI with using a UV/visbile spectrophotometer.

Secondary Outcome Measures