NCT00387114

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
Last Updated

October 12, 2006

Status Verified

October 1, 2006

First QC Date

October 10, 2006

Last Update Submit

October 10, 2006

Conditions

Metabolic DiseasesOxidative Stress

Keywords

C-reactive proteinnitrotyrosineoxidative stressresistinvitamin C

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Vitamin CDRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, University of Turin

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Gianfranco Pagano, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

June 1, 2005

Study Completion

November 1, 2005

Last Updated

October 12, 2006

Record last verified: 2006-10

Locations

IT(1)