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Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial

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: NCT00465946
Recruitment Status : Unknown
Verified April 2007 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2007
Last Update Posted : April 27, 2007
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE April 24, 2007
First Posted Date  ICMJE April 27, 2007
Last Update Posted Date April 27, 2007
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2007)
Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2007)
  • Evaluate the supplementation salt increases the orthostatic tolerance
  • Analyze the supplementation salt increases the plasmatic volume
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial
Official Title  ICMJE Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial
Brief Summary Syncope is a syndrome consisting of a relatively short period of temporary and self-limited loss of consciousness caused by transient diminution of blood flow to the brain (most often the result of systemic hypotension). The objective of this study was to evaluate the effect of salt supplementation in vasovagal syncope prophylaxis.
Detailed Description Healthy volunteers without use of medicines with except contraceptives orals that met the exclusion criteria were consecutively enrolled in a randomized trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: Salt Supplementation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: April 25, 2007)
20
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Use medicines
  • Previous diseases
  • Incapacity of to understand and to sign the term consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465946
Other Study ID Numbers  ICMJE HCPA04-071
HCPA04-071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leandro I Zimerman, MD Associate Professor
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP