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
Recruitment status was Active, not recruiting
Sponsor:
Hospital de Clinicas de Porto Alegre
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
| Tracking Information | |||||
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| First Received Date ICMJE | April 24, 2007 | ||||
| Last Updated Date | April 25, 2007 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the effectiveness of the salt supplementation in the prophylaxis of the vasovagal syncope | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00465946 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial | ||||
| Official Title ICMJE | Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial | ||||
| 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. |
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| Detailed Description | Healthy volunteers without use of medicines with except contraceptives orals that met the exclusion criteria were consecutively enrolled in a randomized trial. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Behavioral: Salt Supplementation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00465946 | ||||
| Other Study ID Numbers ICMJE | HCPA04-071, HCPA04-071 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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