NCT00801034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

August 21, 2015

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

December 2, 2008

Last Update Submit

August 19, 2015

Conditions

Hypertension

Keywords

hypertensionpotassiumblood pressure

Outcome Measures

Primary Outcomes (1)

  • Effect on blood pressure

    three months

Study Arms (2)

1

PLACEBO COMPARATOR

Calcium tablets

Drug: Calcium

2

ACTIVE COMPARATOR

Potassium tablets

Drug: Potassium

Interventions

CalciumDRUG

tablets, 1 tablet 2 times per day in 28 days

1
PotassiumDRUG

Tablets, 5 tablets 2 times per day for 28 days

2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • age 18-40 years old
  • BMI 18, 5-30
  • non-smoker

You may not qualify if:

  • daily use of medicine
  • alcohol or drugs
  • desire to become pregnant
  • not using safe anti-contraceptive
  • abnormal results in the initial testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medical research

Holstebro, Holstebro, 7500, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 22149452DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

CalciumPotassium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsMetals, AlkaliMetals, Light

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, chief physician

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 21, 2015

Record last verified: 2011-12

Locations

DK(1)