Oral Sodium Blood Pressure in Normal Weight, Overweight a... | NCT01532401

Studies
Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers

NCT01532401

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

51Actual

Phase

Phase 2

Conditions

Obesity

Interventions

sodium chloride
Methylcellulose crystalline

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Not provided

First Submitted Date

Feb 9, 2012

First Submission Date that Met QC Criteria

Feb 13, 2012

First Posted Date

Feb 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chlorure de sodium	Experimental		Other: sodium chloride
Methylcellulose	Placebo Comparator		Other: Methylcellulose crystalline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium chloride	Other	sodium chloride 500mg	chlorure de sodium
Methylcellulose crystalline

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samy HADJADJ, MD	CHU DE POITIERS-Service d'endocrinologie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poitiers University Hospital		Poitiers		86021	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided