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

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Calcium Drug: Potassium	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Calcium High Blood Pressure Potassium

Drug Information available for: Potassium bicarbonate Calcium Gluconate Potassium chloride

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:

Effect on blood pressure [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	November 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Calcium tablets	Drug: Calcium tablets, 1 tablet 2 times per day in 28 days
Active Comparator: 2 Potassium tablets	Drug: Potassium Tablets, 5 tablets 2 times per day for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801034

Locations

Denmark
Department of medical research
Holstebro, Denmark, 7500

Sponsors and Collaborators

Regional Hospital Holstebro

More Information

No publications provided by Regional Hospital Holstebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Regional Hospital Holstebro
ClinicalTrials.gov Identifier:	NCT00801034 History of Changes
Other Study ID Numbers:	MED.RES.HOS.2008.01.SKM
Study First Received:	December 2, 2008
Last Updated:	December 5, 2011
Health Authority:	Denmark: Danish Dataprotection Agency

Keywords provided by Regional Hospital Holstebro:

hypertension
potassium
blood pressure

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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