HypertensionPhase 1NCT00801034
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
A Phase 1 study testing Calcium and Potassium in people with Hypertension, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Calcium and Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2008to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- age 18-40 years old
- BMI 18, 5-30
- non-smoker
Who cannot join
- daily use of medicine
- alcohol or drugs
- desire to become pregnant
- not using safe anti-contraceptive
- abnormal results in the initial testing
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- Calcium, Potassium
- Keywords
- hypertension, potassium, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDrug
tablets, 1 tablet 2 times per day in 28 days
PotassiumDrug
Tablets, 5 tablets 2 times per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Calcium tablets Receives: Drug: Calcium |
| 2 | Active comparator | Potassium tablets Receives: Drug: Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on blood pressure
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801034
- Sponsor's protocol ID
- MED.RES.HOS.2008.01.SKM
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2008
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22149452
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801034
- Acronym / sponsor ID
- MED.RES.HOS.2008.01.SKM
- Conditions
- Hypertension
- Keywords
- hypertension, potassium, blood pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: CalciumCalcium tablets |
| 2 | Active comparator | Drug: PotassiumPotassium tablets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- age 18-40 years old
- BMI 18, 5-30
- non-smoker
Key exclusion criteria (5 listed)
- daily use of medicine
- alcohol or drugs
- desire to become pregnant
- not using safe anti-contraceptive
- abnormal results in the initial testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calciumtablets, 1 tablet 2 times per day in 28 days | Drug | 1 |
| PotassiumTablets, 5 tablets 2 times per day for 28 days | Drug | 2 |
Primary outcome
Effect on blood pressure
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Derived from this study: PubMed 22149452Matthesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium and Potassium in people with Hypertension, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on blood pressure (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.