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

Primary Purpose

Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Salt Supplementation
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Salt supplementation, Vasovagal syncope, Orthostatic tolerance, Healthy volunteers

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Use medicines
  • Previous diseases
  • Incapacity of to understand and to sign the term consent

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Outcomes

Primary Outcome Measures

Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope

Secondary Outcome Measures

Evaluate the supplementation salt increases the orthostatic tolerance
Analyze the supplementation salt increases the plasmatic volume

Full Information

First Posted
April 24, 2007
Last Updated
April 25, 2007
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT00465946
Brief Title
Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial
Official Title
Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Salt supplementation, Vasovagal syncope, Orthostatic tolerance, Healthy volunteers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Salt Supplementation
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope
Secondary Outcome Measure Information:
Title
Evaluate the supplementation salt increases the orthostatic tolerance
Title
Analyze the supplementation salt increases the plasmatic volume

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Use medicines Previous diseases Incapacity of to understand and to sign the term consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leandro I Zimerman, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.hcpa.ufrgs.br
Description
The Hospital of Clinics of Porto Alegre is a Public Company of Right Private member of the net of academical hospitals of Ministry of Education and linked academically to the Federal University of Rio Grande do Sul.

Learn more about this trial

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

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