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

NCT01876563 | Unknown Phase 4 DMC

• 1 other identifier: 17112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Type 2 Diabetes

Keywords

thioredoxin; TBP-2; thioredoxin reductase; vitamin D; DIABETES

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• GENE EXPRESSION OF TBP-2

  change from baseline at 2 months

Study Arms (2)

diabetes, vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: vitamin D

placebo, diabetes

PLACEBO COMPARATOR

patients with type 2 diabetes who receive one tab placebo

Dietary Supplement: placebo

Interventions

vitamin D DIETARY_SUPPLEMENT

one tab 4000 IU/day vitamin D

diabetes, vitamin D

placebo DIETARY_SUPPLEMENT

one tab per day placebo

placebo, diabetes

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (2)

Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 12, 2013
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

IR (2)