NCT00000509

Brief Summary

To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1983

Longer than P75 for phase_3 cardiovascular-diseases

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

September 1, 1983

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

20 years

First QC Date

October 27, 1999

Last Update Submit

March 14, 2017

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

diet, sodium-restrictedBEHAVIORAL
diet, potassium-supplementationBEHAVIORAL

Eligibility Criteria

Age45 Years - 68 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men, ages 45 to 68. Subjects were hypertensive, were treated for at least 3.5 years with antihypertensive drugs and whose diastolic blood pressure was less than 90 mm Hg.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Grimm RH, Kofron PM, Neaton JD, Svendsen KH, Elmer PJ, Holland L, Witte L, Clearman D, Prineas RJ. Effect of potassium supplementation combined with dietary sodium reduction on blood pressure in men taking antihypertensive medication. J Hypertens Suppl. 1988 Dec;6(4):S591-3. doi: 10.1097/00004872-198812040-00185.

    PMID: 3241259BACKGROUND

  • Grimm RH Jr, Neaton JD, Elmer PJ, Svendsen KH, Levin J, Segal M, Holland L, Witte LJ, Clearman DR, Kofron P, et al. The influence of oral potassium chloride on blood pressure in hypertensive men on a low-sodium diet. N Engl J Med. 1990 Mar 1;322(9):569-74. doi: 10.1056/NEJM199003013220901.

    PMID: 2406601BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

Diet, Sodium-RestrictedDiet

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1983

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share