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Effect of Salt Restriction on Renin Activation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turkish Society of Hypertension and Renal Diseases
ClinicalTrials.gov Identifier:
NCT01628302
First received: June 13, 2012
Last updated: June 22, 2012
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Behavioral: Lowering salt in diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of Salt Restriction Effect on Renin Activation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turkish Society of Hypertension and Renal Diseases:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in sodium levels in urine samples. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Sodium was measured in 24-hour collected urine samples 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.

  • Change in plasma renin activity [ Time Frame: For 3 times in 8 weeks ] [ Designated as safety issue: No ]
    Plasma renin activity level was measured in the blood samples collected, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

  • Change in aldosterone level in blood samples [ Time Frame: For 3 times in 8 weeks ] [ Designated as safety issue: No ]
    Aldosterone levels was measured in the blood samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

  • Change in potassium levels in urine samples. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Potassium was measured in 24-hour collected urine samples 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.

  • Change in urea level in urine samples [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Urea was measured in 24-hour collected urine samples 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

  • Change in creatinin level in urine samples [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Creatinin was measured in 24-hour collected urine samples 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.

  • Change in microalbumin level in urine samples [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Microalbumin was measured in 24-hour collected urine samples 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

  • Change in aldosterone level in urine samples [ Time Frame: For 3 times in 8 weeks ] [ Designated as safety issue: No ]
    Aldosterone levels was measured in in the 24-hour urine samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.


Enrollment: 28
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normal salt diet
The group had normal salt diet (250mmol)for three 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 had low salt diet (50mmol) at the last 3 weeks of the study.
Experimental: Low salt diet
The group had low salt diet (50mmol)for three 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 had normal salt diet at the last 3 weeks of the study.
 Behavioral: Lowering salt in diet
Low salt diet (50mmol)for three weeks.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who are 50 years and older
  • Subjects whose systolic blood pressure is ≥ 140 mmHg
  • Subjects whose diastolic blood pressure is ≥ 90 mmHg
  • Subjects who is normal weighted defined as body mass index < 25 or who is obese defined as body mass index > 30
  • Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
  • Informed about the study and consented to include the study

Exclusion Criteria:

  • Known heart failure
  • Known renal failure
  • Known chronic liver disease
  • Antihypertensive drug use
  • nonsteroidal anti inflammatory (NSAI) drug use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628302

Sponsors and Collaborators
Turkish Society of Hypertension and Renal Diseases
Investigators
Principal Investigator: Mustafa Arici, Prof. Hacettepe University Faculty of Medicine Department of Nephrology
  More Information

No publications provided

Responsible Party: Turkish Society of Hypertension and Renal Diseases
ClinicalTrials.gov Identifier: NCT01628302     History of Changes
Other Study ID Numbers: HT-Salt
Study First Received: June 13, 2012
Last Updated: June 22, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Turkish Society of Hypertension and Renal Diseases:
Hypertension,plasma renin activity,salt consumption

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013