Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers (PLADSEL)

October 10, 2016 updated by: Poitiers University Hospital

Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult

The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • Poitiers university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Age 18-45 for adults and 6-8 for children

Exclusion Criteria:

  • African ethnicity (known to affect blood pressure sensitivity to salt)
  • Chronic condition affecting blood pressure
  • Diabetes (known to affect blood pressure sensitivity to salt)
  • Hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chlorure de sodium
Other: sodium chloride
sodium chloride 500mg
Placebo Comparator: Methylcellulose
Other: Methylcellulose crystalline
Methylcellulose 37 ml

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Samy HADJADJ, MD, CHU DE POITIERS-Service d'endocrinologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 13, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLADSEL 2010-023410-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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