Effect of Salt Restriction on Renin Activation
Tracking Information | |||||
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First Received Date ICMJE | June 13, 2012 | ||||
Last Updated Date | June 22, 2012 | ||||
Start Date ICMJE | March 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] 24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01628302 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 | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Salt Restriction on Renin Activation | ||||
Official Title ICMJE | Investigation of Salt Restriction Effect on Renin Activation | ||||
Brief Summary | The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects. Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects. |
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Detailed Description | The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study. At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects. 24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Hypertension | ||||
Intervention ICMJE | Behavioral: Lowering salt in diet
Low salt diet (50mmol)for three weeks. |
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Study Arm (s) |
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Publications * | |||||
* 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 | Completed | ||||
Enrollment ICMJE | 28 | ||||
Completion Date | July 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01628302 | ||||
Other Study ID Numbers ICMJE | HT-Salt | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Turkish Society of Hypertension and Renal Diseases | ||||
Study Sponsor ICMJE | Turkish Society of Hypertension and Renal Diseases | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Turkish Society of Hypertension and Renal Diseases | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |