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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01876563
• Other study ID #: 17112
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 10, 2013
• Last updated: June 10, 2013
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• vitamin D
one tab 4000 IU/day vitamin D
• placebo
one tab per day placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum total cholesterol		change from baseline at 2 months	No
Primary	serum HDL cholesterol		change from baseline at 2 months	No
Primary	serum triglycerides level		change from baseline at 2 months	No
Primary	fasting plasma glucose		change from baseline at 2 months	No
Primary	serum LDL cholesterol		change from baseline at 2 months	No
Primary	complete blood count (CBC)		change from baseline at 2 months	No
Primary	HbA1c		change from baseline at 2 months	No
Primary	serum insulin		change from baseline at 2 months	No
Primary	serum calcidiol		change from baseline at 2 months	No
Primary	thioredoxin		change from baseline at 2 months	No
Primary	thioredoxin binding protein 2 (TBP-2)		change from baseline at 2 months	No
Primary	erytrocyte thioredoxin reductase		change from baseline at 2 months	No
Secondary	GENE EXPRESSION OF TBP-2		change from baseline at 2 months	No