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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01876563
Other study ID # 17112
Secondary ID
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


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
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