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

This study has been terminated.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00387114
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00387114     History of Changes
Other Study ID Numbers: 2005-002368-27
Study First Received: October 10, 2006
Last Updated: October 10, 2006
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013