NCT00700479

Brief Summary

A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

June 18, 2008

Status Verified

June 1, 2008

Enrollment Period

2.4 years

First QC Date

December 25, 2007

Last Update Submit

June 17, 2008

Conditions

Inflammation

Keywords

vascular endotheliumnitric oxidealdosteronevascular biology

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilation brachial artery

    0 and 4 hours

Study Arms (4)

A

EXPERIMENTAL

Aldosterone plus low salt diet

Drug: aldosteroneDietary Supplement: low or high sodium diet

B

EXPERIMENTAL

Aldosterone plus high sodium diet

Drug: aldosteroneDietary Supplement: low or high sodium diet

C

PLACEBO COMPARATOR

Placebo plus low sodium diet

Dietary Supplement: low or high sodium dietDrug: placebo

D

PLACEBO COMPARATOR

placebo plus high sodium diet

Dietary Supplement: low or high sodium dietDrug: placebo

Interventions

aldosteroneDRUG

4 hour infusion

AB
low or high sodium dietDIETARY_SUPPLEMENT
ABCD
placeboDRUG

placebo

CD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects age \>18 years

You may not qualify if:

  • Any chronic medical disease or chronic use of medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Aldosterone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Stuart Katz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 25, 2007

First Posted

June 18, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 18, 2008

Record last verified: 2008-06

Locations

US(1)