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

NCT ID: NCT01876563

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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diabetes, vitamin D

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

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

one tab 4000 IU/day vitamin D

placebo, diabetes

patients with type 2 diabetes who receive one tab placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

one tab per day placebo

Interventions

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vitamin D

one tab 4000 IU/day vitamin D

Intervention Type DIETARY_SUPPLEMENT

placebo

one tab per day placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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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Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Tehran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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17112

Identifier Type: -

Identifier Source: org_study_id

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