Effect of no Added Salt Diet on Urinary Sodium and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491881
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : August 3, 2007
Information provided by:
Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: no added salt diet Not Applicable

Detailed Description:

Abstract Incidence of Hypertension as a major cardiovascular treat is increasing. The best known diet for hypertensives is 'no added salt diet'.

In this study we evaluated the effect of 'no added salt diet' on hypertensive population with high dietary sodium intake by measuring 24 hour urinary sodium excretion.

Method & results: In this single center randomized study 80 patients (60 cases and 20 controls) not on any drug therapy for hypertension with mild to moderate hypertension were enrolled. 24 hour holter monitoring of BP and 24 hour urinary sodium excretion were measured before and after 6 weeks of 'no added salt diet'. There is no statistically significant difference between age , weight , sex , Hyperlipidemia , family history of hypertension , mean systolic & diastolic BP at day and night and mean urinary sodium excretion in 24 hour urine of case &control groups .78% of all patients had moderate to high salt intake .

After 6 week of 'no added salt diet' systolic & diastolic BP significantly decreased at day (mean decrease: 12.1 /6.8 mmhg) and night (mean decrease: 11.1/5.9 mmhg ) which is statistically significant between case & control groups (P 0.0001).

Urinary sodium excretion of 24 hour urine decreased 37.1meq/d ± 39,67mg/dl which is statistically significant in case & control groups (p: 0.0001).

Only 36% of patients after no added salt diet reach to pretreatment goal of 24 hour urinary sodium excretion of below 100meq/dl (P:0.001).

Conclusion: despite modest effect on dietary sodium restriction, no added salt diet significantly decreases systolic & diastolic BP and should be advised to every hypertensive patients. Trial registration research deputy-smums84-2384 Key words: blood pressure, No added salt diet, urinary sodium

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2005 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of "no Added Salt Diet " on Blood Pressure Control & 24 Hour Urinary Sodium Excretion in Mild to Moderate Hypertension
Study Start Date : May 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
U.S. FDA Resources

Primary Outcome Measures :
  1. decrease blood pressure [ Time Frame: after 6 weeks of diet ]

Secondary Outcome Measures :
  1. decrease 24 hours urinary sodium excretion [ Time Frame: after 6 weeks of diet ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491881

Iran, Islamic Republic of
Motahhari outpatient clinic
Shiraz, Fars, Iran, Islamic Republic of, 71936-36143
Sponsors and Collaborators
Shiraz University of Medical Sciences
Study Director: javad kojuri, M.D. Shiraz University of Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00491881     History of Changes
Other Study ID Numbers: 2384
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: August 3, 2007
Last Verified: June 2007

Keywords provided by Shiraz University of Medical Sciences:
blood pressure
No added salt diet
urinary sodium

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases