NCT00590512

Brief Summary

The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Mar 2005

Longer than P75 for early_phase_1 healthy

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

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

7.7 years

First QC Date

December 28, 2007

Last Update Submit

August 28, 2013

Conditions

Healthy

Keywords

dietary saltsodiumblood vesselsvascular functionendothelial functionheart disease riskcardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    one week

Study Arms (2)

High Sodium

ACTIVE COMPARATOR

High sodium

Dietary Supplement: High sodium

Low sodium

ACTIVE COMPARATOR

Low sodium

Dietary Supplement: Low sodium

Interventions

High sodiumDIETARY_SUPPLEMENT
High Sodium
Low sodiumDIETARY_SUPPLEMENT
Low sodium

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male, African-American volunteers
  • years of age,
  • No personal or first degree relative with hypertension or diabetes,
  • Blood pressure \<130/85 mmHg and \> 90/60 at the screening visit,
  • Body mass index \<30 kg/m2,
  • No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).

You may not qualify if:

  • Alcohol intake \>2 beverage/night,
  • Smoking,
  • Recreational drug use,
  • Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
  • Prescription or herbal medication use,
  • Ischemic changes on resting electrocardiogram,
  • Known hypersensitivity to any of the study drugs,
  • Other active medical problems detected by examination or laboratory testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rhonda Bentley-Lewis, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 10, 2008

Study Start

March 1, 2005

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

US(1)