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NCT00465946 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00465946
Other study ID # HCPA04-071
Secondary ID HCPA04-071
Status Active, not recruiting
Phase N/A
First received April 24, 2007
Last updated April 25, 2007
Start date June 2004
Est. completion date June 2007

Study information
Verified date April 2007
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Use medicines

- Previous diseases

- Incapacity of to understand and to sign the term consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Salt Supplementation

Locations
Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope
Secondary Evaluate the supplementation salt increases the orthostatic tolerance
Secondary Analyze the supplementation salt increases the plasmatic volume
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