MedTrace Logo

Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects

NCT02561325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2016-07-26

No results posted yet for this study

Summary

Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.

In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."

"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.

In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.

Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.

Conditions

  • Healthy

Interventions

DRUG

Sodium Bicarbonate and Sodium chloride

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Claude DUBRAY · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-01-31
Completion
2017-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561325 on ClinicalTrials.gov