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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014