The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Regional Hospital Holstebro

ClinicalTrials.gov Identifier:

NCT00801034

First received: December 2, 2008

Last updated: December 5, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 2, 2008
Last Updated Date	December 5, 2011
Start Date ^ICMJE	November 2008
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2008)	Effect on blood pressure [ Time Frame: three months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00801034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
Official Title ^ICMJE	The Effects of Potassium on Physiological Variables in the Kidney and Cardiovascular Variables in Healthy Persons in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study
Brief Summary	In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if the development of hypertension has a connection to our intake of potassium. We know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: Calcium tablets, 1 tablet 2 times per day in 28 days Drug: Potassium Tablets, 5 tablets 2 times per day for 28 days
Study Arm (s)	Placebo Comparator: 1 Calcium tablets Intervention: Drug: Calcium Active Comparator: 2 Potassium tablets Intervention: Drug: Potassium
Publications *	Matthesen SK, Larsen T, Vase H, Lauridsen TG, Pedersen EB. Effect of potassium supplementation on renal tubular function, ambulatory blood pressure and pulse wave velocity in healthy humans. Scand J Clin Lab Invest. 2012 Feb;72(1):78-86. Epub 2011 Dec 12.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy age 18-40 years old BMI 18, 5-30 non-smoker Exclusion Criteria: daily use of medicine alcohol or drugs desire to become pregnant not using safe anti-contraceptive abnormal results in the initial testing
Gender	Both
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00801034
Other Study ID Numbers ^ICMJE	MED.RES.HOS.2008.01.SKM
Has Data Monitoring Committee	Yes
Responsible Party	Regional Hospital Holstebro
Study Sponsor ^ICMJE	Regional Hospital Holstebro
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Regional Hospital Holstebro
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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