Increasing Potassium Intake in Hypertensive Individuals
Adequate Intake of Potassium Does Not Cause Hyperkalemia in Hypertensive Individuals on Medications That Antagonize the Renin Angiotensin Aldosterone System
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
This study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Mar 2008
Longer than P75 for not_applicable hypertension
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
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedMay 25, 2017
May 1, 2017
7.3 years
December 22, 2015
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum potassium concentration
4 weeks
Secondary Outcomes (2)
24 hour urinary potassium excretion
4 weeks
3 day dietary food diary
4 weeks
Study Arms (2)
High potassium diet group
EXPERIMENTALIndividuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables.
Usual diet group
NO INTERVENTIONIndividuals in this group were asked to continue habitual dietary intake.
Interventions
An increase in consumption of high potassium fruits and vegetables
Eligibility Criteria
You may qualify if:
- Medically treated hypertension as diagnosed Hypertension was established by the participant's cardiologist or if recruited from the online community hypertension was self-reported and confirmed by study investigators based on participant's medical prescription.
- Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous 3 months
- K+ intake at baseline of less than 80 mmol/day (food diary of 24 hour food recall).
You may not qualify if:
- Patients with an episode of acute coronary syndrome, or revascularization within the previous 3 months will not be included.
- Serum K+ concentration 5.0 mmol/L
- Serum creatinine \> 130 mmol/L.
- Inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Malta D, Arcand J, Ravindran A, Floras V, Allard JP, Newton GE. Adequate intake of potassium does not cause hyperkalemia in hypertensive individuals taking medications that antagonize the renin angiotensin aldosterone system. Am J Clin Nutr. 2016 Oct;104(4):990-994. doi: 10.3945/ajcn.115.129635. Epub 2016 Aug 31.
PMID: 27581475DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Treating physicians and participants were not blinded to randomization. Investigators performing randomization and analysis of dietary intake were blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
May 3, 2016
Study Start
March 1, 2008
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 25, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share