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Effect of an Anti-Oxidant Treatment on Resistin Serum Levels.A Randomized Study

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387114
First Posted: October 12, 2006
Last Update Posted: October 12, 2006
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.
Information provided by:
University of Turin, Italy
  Purpose
The aim of the present study was to evaluate whether an in vivo treatment with an antioxidant vitamin (vitamin C) might substantially affect serum levels of resistin, a recently described adipokine, whose clinical significance is still controversial in humans.

Condition Intervention Phase
Metabolic Diseases Oxidative Stress Drug: Vitamin C Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of an Anti-Oxidant Treatment on Resistin Serum Levels.A Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Mean resistin serum level reduction, after vitamin C treatment, of at least 0.50 standardized units.

Secondary Outcome Measures:
  • The within- and between-group variations in the other inflammatory and oxidative variables measured.

Estimated Enrollment: 80
Study Start Date: June 2005
Estimated Study Completion Date: November 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 20-50 years
  • absence of known hyperglycemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions no use of any drug, estrogen included
  • not being on a particular diet and/or vitamin or other nutrient supplementation

Exclusion Criteria:

  • actual pregnancy
  • known hyperglycemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions
  • use of any drug, estrogen included
  • being on a particular diet, vitamin or other nutrient supplementation
  • history of renal calculi.
  Contacts and Locations
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): NCT00387114


Locations
Italy
Department of Internal Medicine, University of Turin
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Gianfranco Pagano, MD University of Turin, Italy
  More Information

ClinicalTrials.gov Identifier: NCT00387114     History of Changes
Other Study ID Numbers: 2005-002368-27
First Submitted: October 10, 2006
First Posted: October 12, 2006
Last Update Posted: October 12, 2006
Last Verified: October 2006

Keywords provided by University of Turin, Italy:
C-reactive protein
nitrotyrosine
oxidative stress
resistin
vitamin C

Additional relevant MeSH terms:
Metabolic Diseases
Vitamins
Ascorbic Acid
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents