Studies on Aldosterone and Vascular Function

Yale University

Status and phase: Completed; Phase 1

Conditions: Inflammation

Treatments: Drug: placebo; Dietary Supplement: low or high sodium diet; Drug: aldosterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00700479

602001143

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects age >18 years

Exclusion criteria

• Any chronic medical disease or chronic use of medications

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

Aldosterone plus low salt diet

Treatment:

Drug: aldosterone

Dietary Supplement: low or high sodium diet

B

Experimental group

Description:

Aldosterone plus high sodium diet

Treatment:

Drug: aldosterone

Dietary Supplement: low or high sodium diet

C

Placebo Comparator group

Description:

Placebo plus low sodium diet

Treatment:

Dietary Supplement: low or high sodium diet

Drug: placebo

D

Placebo Comparator group

Description:

placebo plus high sodium diet

Treatment:

Dietary Supplement: low or high sodium diet

Drug: placebo