Effect of Salt Restriction on Renin Activation

NCT ID: NCT01628302

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Lowering salt in diet

Intervention Type: BEHAVIORAL

Low salt diet (50mmol)for three weeks.

Interventions

Lowering salt in diet

Low salt diet (50mmol)for three weeks.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Turkish Society of Hypertension and Renal Diseases

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustafa Arici, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Faculty of Medicine Department of Nephrology

Other Identifiers

HT-Salt

Identifier Type: -

Identifier Source: org_study_id