- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00491881
Effect of no Added Salt Diet on Urinary Sodium and Blood Pressure
Effect of "no Added Salt Diet " on Blood Pressure Control & 24 Hour Urinary Sodium Excretion in Mild to Moderate Hypertension
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Fars
-
Shiraz, Fars, Iran, Islamisk Republik, 71936-36143
- Motahhari outpatient clinic
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
decrease blood pressure
Tidsramme: after 6 weeks of diet
|
after 6 weeks of diet
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
decrease 24 hours urinary sodium excretion
Tidsramme: after 6 weeks of diet
|
after 6 weeks of diet
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: javad kojuri, M.D., Shiraz University of Medical Sciences
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2384
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