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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Calcium
Potassium
Sponsored by
Erling Bjerregaard Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, potassium, blood pressure

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of medical research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Calcium tablets

Potassium tablets

Outcomes

Primary Outcome Measures

Effect on blood pressure

Secondary Outcome Measures

Full Information

First Posted
December 2, 2008
Last Updated
August 19, 2015
Sponsor
Erling Bjerregaard Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT00801034
Brief Title
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erling Bjerregaard Pedersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, potassium, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Calcium tablets
Arm Title
2
Arm Type
Active Comparator
Arm Description
Potassium tablets
Intervention Type
Drug
Intervention Name(s)
Calcium
Intervention Description
tablets, 1 tablet 2 times per day in 28 days
Intervention Type
Drug
Intervention Name(s)
Potassium
Intervention Description
Tablets, 5 tablets 2 times per day for 28 days
Primary Outcome Measure Information:
Title
Effect on blood pressure
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of medical research
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22149452
Citation
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. doi: 10.3109/00365513.2011.635216. Epub 2011 Dec 12.
Results Reference
derived

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

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