the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: placebo

• Registration Number: NCT01876563
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-10
• Last Update Submitted: 2013-06-10
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12
• Primary Completion: 2014-02
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

Exclusion Criteria

people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetes, vitamin D	vitamin D	patients with type 2 diabetes who receive 4000 IU/day vitamin D
placebo, diabetes	placebo	patients with type 2 diabetes who receive one tab placebo

Primary Outcome Measures

Name	Time	Method
serum total cholesterol	change from baseline at 2 months
serum HDL cholesterol	change from baseline at 2 months
serum triglycerides level	change from baseline at 2 months
fasting plasma glucose	change from baseline at 2 months
serum LDL cholesterol	change from baseline at 2 months
complete blood count (CBC)	change from baseline at 2 months
HbA1c	change from baseline at 2 months
serum insulin	change from baseline at 2 months
serum calcidiol	change from baseline at 2 months
thioredoxin	change from baseline at 2 months
thioredoxin binding protein 2 (TBP-2)	change from baseline at 2 months
erytrocyte thioredoxin reductase	change from baseline at 2 months

Secondary Outcome Measures

Name	Time	Method
GENE EXPRESSION OF TBP-2	change from baseline at 2 months

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of