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

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: vitamin D; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
serum LDL cholesterol	change from baseline at 2 months
serum insulin	change from baseline at 2 months
fasting plasma glucose	change from baseline at 2 months
complete blood count (CBC)	change from baseline at 2 months
HbA1c	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

Outcome Measure	Time Frame
GENE EXPRESSION OF TBP-2	change from baseline at 2 months

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: vitamin D; thioredoxin; TBP-2; thioredoxin reductase; DIABETES
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 17112