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

NCT00801034 — Phase 1, Completed, 25 participants, Erling Bjerregaard Pedersen

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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

RegistryNCT00801034
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment25 (Actual)
SponsorErling Bjerregaard Pedersen (Other)
ConditionsHypertension
InterventionsCalcium, Potassium (Drug)
Datesstart 2008-11-01, primary completion 2011-11-01, completion 2011-11-01, first posted 2008-12-03, last updated 2015-08-21
Locations1 site in Denmark

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
1Placebo comparatorDrug: CalciumCalcium tablets
2Active comparatorDrug: PotassiumPotassium tablets
  • Calcium (Drug): tablets, 1 tablet 2 times per day in 28 days
  • Potassium (Drug): Tablets, 5 tablets 2 times per day for 28 days

+Outcome measures

Primary outcomes

  • Effect on blood pressure [three months]

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts 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

+Locations (1)

FacilityCityCountryStatus
Department of medical researchHolstebro, HolstebroDenmark

+Publications

  • Results publication: 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 22149452

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