## Protocol Section
### Identification Module
**NCT ID:** NCT00700479

**Brief Title:** Studies on Aldosterone and Vascular Function

**Official Title:** Studies on Aldosterone and Vascular Function

#### Organization Study ID Info
**ID:** 602001143
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-06-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-06-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Start Date
**Date:** 2006-01

**Status Verified Date:** 2008-06

#### Study First Post Date
**Date:** 2008-06-18
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-25
**Study First Submit QC Date:** 2008-06-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Pfizer

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Old Name Title:** Stuart Katz

**Old Organization:** Yale School of Medicine

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Inflammation

**Keywords:**

- vascular endothelium

- nitric oxide

- aldosterone

- vascular biology

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Aldosterone plus low salt diet

**Intervention Names:**

- Drug: aldosterone

- Dietary Supplement: low or high sodium diet

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Aldosterone plus high sodium diet

**Intervention Names:**

- Drug: aldosterone

- Dietary Supplement: low or high sodium diet

**Label:** B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo plus low sodium diet

**Intervention Names:**

- Dietary Supplement: low or high sodium diet

- Drug: placebo

**Label:** C

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** placebo plus high sodium diet

**Intervention Names:**

- Dietary Supplement: low or high sodium diet

- Drug: placebo

**Label:** D

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

- B

**Description:** 4 hour infusion

**Name:** aldosterone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- A

- B

- C

- D

**Name:** low or high sodium diet

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- C

- D

**Description:** placebo

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Flow mediated dilation brachial artery

**Time Frame:** 0 and 4 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy subjects age \>18 years

Exclusion Criteria:

* Any chronic medical disease or chronic use of medications

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Haven

**Country:** United States

**Facility:** Yale University School of Medicine

**State:** Connecticut

**Zip:** 06510

#### Overall Officials

**Official 1:**

**Affiliation:** Yale School of Medicine

**Name:** Stuart Katz, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12507

- Name: Nitric Oxide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
