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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Hospital de Clinicas de Porto Alegre Fundo de Incentivo a Pesquisa (FIPE-HCPA)
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00465946

Purpose

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.

Condition	Intervention
Healthy	Behavioral: Salt Supplementation

MedlinePlus related topics: Dietary Sodium Fainting

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial

Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Estimated Enrollment:	20
Study Start Date:	June 2004
Estimated Study Completion Date:	June 2007

Detailed Description:

Healthy volunteers without use of medicines with except contraceptives orals that met the exclusion criteria were consecutively enrolled in a randomized trial.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465946

Locations

Brazil, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Fundo de Incentivo a Pesquisa (FIPE-HCPA)

Investigators

Principal Investigator:

Leandro I Zimerman, MD

Associate Professor

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	HCPA04-071, HCPA04-071
Study First Received:	April 24, 2007
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00465946
Health Authority:	Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:

Salt supplementation
Vasovagal syncope
Orthostatic tolerance
Healthy volunteers

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Consciousness Disorders
Neurologic Manifestations

Healthy
Neurobehavioral Manifestations
Syncope
Syncope, Vasovagal

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009