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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01532401
First received: February 9, 2012
Last updated: October 10, 2016
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Other: sodium chloride
Other: Methylcellulose crystalline
Phase 2

Study Type: Interventional
Official Title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Enrollment: 51
Study Start Date: March 2011
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorure de sodium Other: sodium chloride
sodium chloride 500mg
Placebo Comparator: Methylcellulose Other: Methylcellulose crystalline
Methylcellulose 37 ml

  Eligibility

Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532401

Locations
France
Poitiers University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Samy HADJADJ, MD CHU DE POITIERS-Service d'endocrinologie
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01532401     History of Changes
Other Study ID Numbers: PLADSEL 2010-023410-31 
Study First Received: February 9, 2012
Last Updated: October 10, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Poitiers University Hospital:
Blood pressure

ClinicalTrials.gov processed this record on December 09, 2016