Comparison of the influence of low-dose supplementation with potassium citrate or potassium chloride on blood pressure, plasma and erythrocyte electrolyte concentrations and bone health biomarkers

ISRCTN	ISRCTN52748737
DOI	https://doi.org/10.1186/ISRCTN52748737
Secondary identifying numbers	02/03-53

Submission date: 15/09/2005
Registration date: 28/04/2006
Last edited: 06/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Donald J Naismith
Scientific

Deparment of Nutrition and Dietetics
Franklin Wilkins Building
King's College London
150 Stamford Street
London
SW4 7RJ
United Kingdom

Study information

Study design	Randomised, double-blind, placebo-controlled trial with a parallel arm design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Comparison of the influence of low-dose supplementation with potassium citrate or potassium chloride on blood pressure, plasma and erythrocyte electrolyte concentrations and bone health biomarkers
Study objectives	It is hypothesised that a sustained supplementation (6 weeks) with low-dose potassium (30 mmol per day), equivalent to the amount present in five portions of fruit and vegetables, would decrease blood pressure and would improve bone metabolism, by reducing bone resorption and increasing bone formation. It is also hypothesized that a non-chloride potassium salt (potassium citrate) when compared to the chloride salts, might promote a further decrease in blood pressure, reduce bone resorption and increase bone formation. Finally it is hypothesised that the potassium-induced decrease in blood pressure might be related to changes in plasma and erythrocyte concentration of sodium and potassium.
Ethics approval(s)	Ethics approval details not yet received as of 28/04/06
Health condition(s) or problem(s) studied	Hypertension and osteoporosis
Intervention	Patients will be randomised to receive one of three treatments: 1. Placebo 2. Potassium citrate 3. Potassium chloride
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Potassium citrate and potassium chloride
Primary outcome measure	1. Mean change in systolic and diastolic blood pressure after 6 weeks of treatment 2. Mean change in biomarkers of bone resorption and bone formation 3. Mean change in erythrocyte and plasma electrolytes concentrations
Secondary outcome measures	Mean change in mean arterial pressure
Overall study start date	16/06/2004
Completion date	29/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	120 healthy volunteers
Key inclusion criteria	To take part in the study, participants will be aged between 22 and 65 years and will have a body mass index (BMI) between 19 and 35 kg/m^2 and alcohol consumption of no more than 21 units (women) or 28 units (men) per week. Volunteers eligible for the study will have the average self-measured systolic blood pressure <160 and average self-measured diastolic blood pressure <105 mmHg (an average of 20 readings for both systolic and diastolic blood pressure). Those with blood pressure levels higher than these values will be advised to contact their general practitioners. Subjects taking medications for which potassium supplementation is not contraindicated, or mineral and vitamin supplements, will be allowed to participate in the study with the provision that they will not discontinue to use these products.
Key exclusion criteria	The main exclusion criteria will be diseases or conditions that might involve collateral effects from potassium supplementation or interfere with its metabolism. These will be insulin dependent diabetes mellitus, non-insulin dependent diabetes mellitus, diabetes insipidus, cardiovascular diseases (including events of cardiac arrhythmia and peripheral arterial disease) or previous cardiovascular events, any kind of renal diseases, metabolic acidosis, current peptic ulcers, dysphagia, general digestive problems, gastric surgery, pregnancy and lactation. Women planning to become pregnant will also be excluded. Other exclusion criteria will be the use of antihypertensive drugs, changes in lifestyle (e.g. dieting, start of new medication), the use of drugs known to interfere with potassium metabolism (cyclosporin, heparin, digoxin, anticholinergics) and prolonged use of non-steroidal anti-inflammatory drugs.
Date of first enrolment	16/06/2004
Date of final enrolment	29/09/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Deparment of Nutrition and Dietetics

London
SW4 7RJ
United Kingdom

Sponsor information

King's College London (UK)
University/education

150 Stamford Street
London
SE1 9NN
England
United Kingdom

"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Industry

All costs related to the running of the trial and are covered by a modest grant (less than £20,000) from the Food and Drink Federation, which is supported by contributions made by affiliated member companies. The study is also partially supported by King's College Enterprises (cost of manufacturing the supplements).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008	06/08/2020	Yes	No

Editorial Notes

06/08/2020: Publication reference added.
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
27/11/2015: No publications found on PubMed.