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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01876563

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: vitamin D Dietary Supplement: placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: diabetes, vitamin D patients with type 2 diabetes who receive 4000 IU/day vitamin D	Dietary Supplement: vitamin D one tab 4000 IU/day vitamin D
Placebo Comparator: placebo, diabetes patients with type 2 diabetes who receive one tab placebo	Dietary Supplement: placebo one tab per day placebo

Arm

Intervention/Treatment

Active Comparator: diabetes, vitamin D

patients with type 2 diabetes who receive 4000 IU/day vitamin D

Dietary Supplement: vitamin D

one tab 4000 IU/day vitamin D

Placebo Comparator: placebo, diabetes

patients with type 2 diabetes who receive one tab placebo

Dietary Supplement: placebo

one tab per day placebo

Outcome Measures

Primary Outcome Measures

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

GENE EXPRESSION OF TBP-2 [change from baseline at 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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