NCT00141622

Brief Summary

Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the "L-arginine-nitric oxide" pathway are thought to be particularly important in these people, and previous research in animals has suggested that sodium (salt) affects part of this metabolic pathway. The purpose of our research is to study the effects of sodium intake on the "L-arginine-nitric oxide" pathway, and on blood vessel function, in patients with kidney disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 15, 2007

Status Verified

August 1, 2005

First QC Date

August 31, 2005

Last Update Submit

May 14, 2007

Conditions

Kidney Failure, Chronic

Keywords

Endothelial dysfunctionADMADDAHSodium

Outcome Measures

Primary Outcomes (4)

  • Under conditions of high (vs. low sodium intake) ...

  • (i) The ratio [ADMA]urine:[DMA]urine is increased

  • (ii) [ADMA]plasma is increased

  • (iii) Endothelium-dependent vasodilatation is reduced

Interventions

Slow sodiumDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD Stages 2 and 3 \[= calculated creatinine clearance of 30 to 89 ml/min/1.73m2 by Cockcroft-Gault formula\]
  • to 75 years old

You may not qualify if:

  • \>3 g/24 hours of proteinuria
  • Uncontrolled hypertension (systolic BP \>160 mmHg, diastolic BP \>100 mmHg on/off anti-hypertensive medication)
  • Diabetes mellitus
  • Tobacco smoking
  • Total fasting cholesterol \>6 mmol/L
  • Uncontrolled heart failure or active IHD
  • Chronic liver failure
  • Active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood Pressure Unit, Department of Cardiac & Vascular Sciences, SGUL

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Timothy WR Doulton, BSc MRCP

    SGUL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

April 1, 2005

Study Completion

October 1, 2006

Last Updated

May 15, 2007

Record last verified: 2005-08

Locations

GB(1)