Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876563
Recruitment Status : Unknown
Verified June 2013 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: vitamin D Dietary Supplement: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. serum total cholesterol [ Time Frame: change from baseline at 2 months ]
  2. serum HDL cholesterol [ Time Frame: change from baseline at 2 months ]
  3. serum triglycerides level [ Time Frame: change from baseline at 2 months ]
  4. fasting plasma glucose [ Time Frame: change from baseline at 2 months ]
  5. serum LDL cholesterol [ Time Frame: change from baseline at 2 months ]
  6. complete blood count (CBC) [ Time Frame: change from baseline at 2 months ]
  7. HbA1c [ Time Frame: change from baseline at 2 months ]
  8. serum insulin [ Time Frame: change from baseline at 2 months ]
  9. serum calcidiol [ Time Frame: change from baseline at 2 months ]
  10. thioredoxin [ Time Frame: change from baseline at 2 months ]
  11. thioredoxin binding protein 2 (TBP-2) [ Time Frame: change from baseline at 2 months ]
  12. erytrocyte thioredoxin reductase [ Time Frame: change from baseline at 2 months ]

Secondary Outcome Measures :
  1. GENE EXPRESSION OF TBP-2 [ Time Frame: change from baseline at 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876563


Locations
Layout table for location information
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Layout table for additonal information
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01876563    
Other Study ID Numbers: 17112
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013
Keywords provided by Tehran University of Medical Sciences:
thioredoxin
TBP-2
thioredoxin reductase
vitamin D
DIABETES
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents