Effect of no Added Salt Diet on Urinary Sodium and Blood Pressure
|ClinicalTrials.gov Identifier: NCT00491881|
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : August 3, 2007
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: no added salt diet||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- decrease blood pressure [ Time Frame: after 6 weeks of diet ]
- decrease 24 hours urinary sodium excretion [ Time Frame: after 6 weeks of diet ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491881
|Iran, Islamic Republic of|
|Motahhari outpatient clinic|
|Shiraz, Fars, Iran, Islamic Republic of, 71936-36143|
|Study Director:||javad kojuri, M.D.||Shiraz University of Medical Sciences|