Condition category
Circulatory System
Date applied
15/09/2005
Date assigned
28/04/2006
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Donald J Naismith

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02/03-53

Study information

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

Acronym

Study hypothesis

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

Ethics approval details not yet received as of 28/04/06

Study design

Randomised, double-blind, placebo-controlled trial with a parallel arm design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Potassium citrate and potassium chloride

Primary outcome measures

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 trial start date

16/06/2004

Overall trial end date

29/09/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 healthy volunteers

Participant 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.

Recruitment start date

16/06/2004

Recruitment end date

29/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Deparment of Nutrition and Dietetics
London
SW4 7RJ
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

150 Stamford Street
London
SE1 9NN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

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).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/11/2015: No publications found on PubMed.