NCT00491881

Brief Summary

There is much evidence that a reduction in dietary salt intake lowers blood pressure in hypertensive individuals, however few have looked at effect of 'no added salt diet' and modest salt intake on total restriction of sodium intake with especial attention to very exact surrogate of urinary sodium excretion. Our study demonstrates that a modest reduction in salt intake from regular level of 10 - 12 g per day to the recommended level of 5 - 6 g per day lowers blood pressure by 12.1/ 6.8 mmHg at day time and 11.1/5.9 mmhg at night time.However only 35% of patients reach to the goal of sodium restriction of diet(below 100 meq/dl in 24 hours urine.It means even modest salt restriction can dramatically decrease blood pressure with no added salt diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,005

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

August 3, 2007

Status Verified

June 1, 2007

First QC Date

June 25, 2007

Last Update Submit

August 2, 2007

Conditions

Keywords

blood pressureNo added salt dieturinary sodium

Outcome Measures

Primary Outcomes (1)

  • decrease blood pressure

    after 6 weeks of diet

Secondary Outcomes (1)

  • decrease 24 hours urinary sodium excretion

    after 6 weeks of diet

Interventions

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension proved by 24 hours holter monitoring
  • Mild to moderate hypertension
  • Signing the written consent

You may not qualify if:

  • Use of any drug for hypertension
  • Use of any drug for 6 week period
  • Unable to collect 24 hours urine
  • Unable to tolerate 24 hours holter of blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motahhari outpatient clinic

Shiraz, Fars, 71936-36143, Iran

Location

Related Publications (1)

  • Kojuri J, Rahimi R. Effect of "no added salt diet" on blood pressure control and 24 hour urinary sodium excretion in mild to moderate hypertension. BMC Cardiovasc Disord. 2007 Nov 6;7:34. doi: 10.1186/1471-2261-7-34.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • javad kojuri, M.D.

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

May 1, 2005

Study Completion

May 1, 2006

Last Updated

August 3, 2007

Record last verified: 2007-06

Locations