Effect of Dietary Salt Supplemantation in Vasovagal Synco... | NCT00465946

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

NCT00465946

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Apr 27, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Healthy

Interventions

Salt Supplementation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HCPA04-071

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Jun 2007Estimated

First Submitted Date

Apr 24, 2007

First Submission Date that Met QC Criteria

Apr 25, 2007

First Posted Date

Apr 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2007

Last Update Posted Date

Apr 27, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Salt Supplementation	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the supplementation salt increases the orthostatic tolerance
Analyze the supplementation salt increases the plasmatic volume

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leandro I Zimerman, MD	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul		Brazil

References Module

Citations

Not provided

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases