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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00465946
First received: April 24, 2007
Last updated: April 25, 2007
Last verified: April 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Leandro I Zimerman, MD Associate Professor
  More Information

Additional Information:
No publications provided

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

Keywords provided by Hospital de Clinicas de Porto Alegre:
Salt supplementation
Vasovagal syncope
Orthostatic tolerance
Healthy volunteers

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014