NCT00160368

Brief Summary

The purpose of this study is to determine the effect of potassium chloride and potassium bicarbonate on blood pressure and also to determine whether increasing potassium intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease, as well as on bone health.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

September 8, 2005

Last Update Submit

April 24, 2007

Conditions

Hypertension

Keywords

Hypertension, potassium salts

Outcome Measures

Primary Outcomes (1)

  • Blood pressure and markers of target organ damage and bone health at 4 weeks of potassium supplementation.

Secondary Outcomes (1)

  • Comparisons among different treatments in blood pressure and markers of target organ damage and bone health.

Interventions

Potassium supplementationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Patients with untreated essential hypertension (sitting systolic blood pressure between 140 and 170 mmHg and/or sitting diastolic blood pressure between 90 and 105 mmHg);
  • Age 18 - 75 years.

You may not qualify if:

  • Individuals younger than 18 or older than 75 years;
  • Individuals with impaired renal function with plasma creatinine greater than 120 umol/L for non-blacks or 150 umol/L for blacks;
  • Individuals with chronic diarrhea, or history of peptic ulcer;
  • Individuals with baseline plasma potassium values greater than 5.0 mmol/L;
  • Individuals with severe hypertension i.e. blood pressure \> 170/105 mmHg;
  • Individuals with diabetes mellitus;
  • Individuals with any secondary cause of hypertension;
  • Individuals with malignancy or liver disease;
  • Individuals with ischaemic heart disease or heart failure;
  • Females who are pregnant or breast feeding or on the oral contraceptive pill.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. George's University of London,

London, SW17 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Graham A MacGregor, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng J He, PhD

CONTACT

0044-20-8725-5375fhe@sgul.ac.uk

Graham A MacGregor, MD

CONTACT

0044-20-8725-5774gmacgregor@sgul.ac.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2005

Study Completion

March 1, 2008

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

GB(1)