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

The effects of vitamin D3 supplementation on some of metabolic and inflammatory markers in patients with diabetic nephropathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201511173140N15
Enrollment
50
Registered
2016-01-17
Start date
2015-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic nephropathy. With renal complications Diabetic nephropathy

Interventions

Intervention 1: Control group: Receiving 1 placebo containing Miglyol oil weekly for 8 weeks. Intervention 2: Intervention group: Receiving vitamin D3 supplement which contains 50,000 IU Pearl vitami
Placebo
Treatment - Drugs
Control group: Receiving 1 placebo containing Miglyol oil weekly for 8 weeks.
Intervention group: Receiving vitamin D3 supplement which contains 50,000 IU Pearl vitamin D3 cholecalciferol weekly for 8 weeks.

Sponsors

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

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Blood pressure. Timepoint: Before and after intervention (8 weeks). Method of measurement: pressure indicator.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsra Esfandiari

Faculty of Nutrition,Tabriz University of Medical Sciences,Tabriz

asra.esfandiari@gmail.com+98 41 3281 9128

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026