NCT00465946

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

April 24, 2007

Last Update Submit

April 25, 2007

Conditions

Healthy

Keywords

Salt supplementationVasovagal syncopeOrthostatic toleranceHealthy volunteers

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Evaluate the supplementation salt increases the orthostatic tolerance

  • Analyze the supplementation salt increases the plasmatic volume

Interventions

Salt SupplementationBEHAVIORAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Links

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leandro I Zimerman, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 27, 2007

Study Start

June 1, 2004

Study Completion

June 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

BR(1)