The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
Sponsor
Erling Bjerregaard Pedersen (Other)
Overall Status
Completed
CT.gov ID
NCT00801034
Collaborator
(none)
25
1
2
36
0.7
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date
:
Nov 1, 2008
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Effect on blood pressure [three months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of medical research | Holstebro | Denmark | 7500 |
Sponsors and Collaborators
- Erling Bjerregaard Pedersen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Erling Bjerregaard Pedersen,
professor, chief physician,
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00801034
Other Study ID Numbers:
- MED.RES.HOS.2008.01.SKM
First Posted:
Dec 3, 2008
Last Update Posted:
Aug 21, 2015
Last Verified:
Dec 1, 2011
Keywords provided by Erling Bjerregaard Pedersen,
professor, chief physician,
Regional Hospital Holstebro
Additional relevant MeSH terms: