Arterial HypertensionNCT01334138
Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care
A study testing A 4-week diet, low in sodium. in people with Arterial Hypertension, run by University Ghent at 1 site in Belgium.
Trial summary
There is strong evidence that our current consumption of salt is the major factor increasing blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the World Health Organization's recommendation is < 5 g/d. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- A 4-week diet, low in sodium.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- May 2010to Apr 2011
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs
- An average systolic bp on 2 of the 3 previous visits of 140 mm Hg or more (130 mm Hg for diabetics) and an average diastolic bp of 80 to 100 mm Hg.
- Blood analysis (fasting glycaemia, creatinin, total cholesterol, high- density lipoprotein cholesterol) in the last 6 months
- At least 3 criteria of the following:
- using table salt
- 2-3/weeks consumption of prepared meals (butchery, warehouse...)
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- 2-3/weeks consumption of effervescent tablet
- Daily consumption of cheese/cold cuts
- Daily consumption of salted butter/margarine
- 2-3/weeks consumption of smoked fish/meat
- 2-3/weeks consumption of bouillon cube-soup (self-made or preserved)
- 2-3/weeks consumption of cookies
- 2-3/weeks consumption of vegetables preserved in jars
- 2-3/weeks consumption of vegetable juice
- 2-3/weeks consumption of snacks (chips, cheese, nuts...)
Who cannot join
- heart failure
- renal insufficiency
- secondary hypertension
- isolated systolic/diastolic hypertension
- bp difference of more than 10 mm Hg between left and right arm
- lactation or pregnancy
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- active malignancy
- an active 'low in salt' diet
- changing the use of antihypertensive drugs or other medication that would affect bp for the last 4 weeks
- impaired cognitive functioning$
- planning a smoke cessation
Trial locations and contacts
1 site in 1 country.
About this study
There is strong evidence that our current consumption of salt is the major factor increasing blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.
The aims of the present study is to determine if the overconsumption of salt influences the bp in patients with uncontrolled hypertension or frequently elevated bp.
Read more
Each study subject will complete questionnaires, and their usual dietary salt intake is estimated from food composition on 3 completed food diaries. This is also compared with a 24-hour urine sample collection.
Based on these results, the study subject receives personal advice to decrease sodium consumption and will change the diet for at least 28 days. During this diet, bp will be measured and food diaries will be completed. After the intervention, a questionnaire and a 24-hour urine sample collection will be collected.
- Conditions
- Arterial Hypertension
- Being tested
- A 4-week diet, low in sodium.
- Keywords
- hypertension, sodium, diet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 4-week diet, low in sodium.Other
Study subjects receive personal advice to decrease sodium consumption and will change his diet for 28 days.
Follow up is performed by measuring blood pressure, a 24-hour urine sample collection, diaries and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 4-week diet, low in sodium | Experimental | The study subjects go on a 4-week diet, low in sodium. Receives: Other: A 4-week diet, low in sodium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood pressure after a 4-week diet, low in sodium.
Measured: after 4 weeks
Secondary outcomes (1)
Life style change after a 4-week diet, low in sodium.
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Stefaan Dehenauw, Ph.D, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334138
- Sponsor's protocol ID
- 2010/233
- Status last verified
- Apr 2012
- First submitted
- 11 Apr 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care
- ClinicalTrials.gov ID
- NCT01334138
- Acronym / sponsor ID
- 2010/233
- Conditions
- Arterial Hypertension
- Keywords
- hypertension, sodium, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Apr 2011 (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.
There is strong evidence that our current consumption of salt is the major factor increasing blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.
The aims of the present study is to determine if the overconsumption of salt influences the bp in patients with uncontrolled hypertension or frequently elevated bp.
Each study subject will complete questionnaires, and their usual dietary salt intake is estimated from food composition on 3 completed food diaries. This is also compared with a 24-hour urine sample collection.
Based on these results, the study subject receives personal advice to decrease sodium consumption and will change the diet for at least 28 days. During this diet, bp will be measured and food diaries will be completed. After the intervention, a questionnaire and a 24-hour urine sample collection will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-week diet, low in sodium | Experimental | Other: A 4-week diet, low in sodium.The study subjects go on a 4-week diet, low in sodium. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs
- An average systolic bp on 2 of the 3 previous visits of 140 mm Hg or more (130 mm Hg for diabetics) and an average diastolic bp of 80 to 100 mm Hg.
- Blood analysis (fasting glycaemia, creatinin, total cholesterol, high- density lipoprotein cholesterol) in the last 6 months
- At least 3 criteria of the following:
Key exclusion criteria (11 listed)
- heart failure
- renal insufficiency
- secondary hypertension
- isolated systolic/diastolic hypertension
- bp difference of more than 10 mm Hg between left and right arm
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 |
|---|---|---|
| A 4-week diet, low in sodium.Study subjects receive personal advice to decrease sodium consumption and will change his diet for 28 days. Follow up is performed by measuring blood pressure, a 24-hour urine sample collection, diaries and questionnaires. | Other | 4-week diet, low in sodium |
Primary outcome
Measurement of blood pressure after a 4-week diet, low in sodium.
Time frame: after 4 weeks
1 secondary outcome
Life style change after a 4-week diet, low in sodium.
Time frame: after 4 weeks
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 23 Apr 2012.
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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.
Stefaan Dehenauw, Ph.D, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 4-week diet, low in sodium. in people with Arterial Hypertension, run by University Ghent at 1 site in Belgium.
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 15 inclusion and 11 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 23 Apr 2012. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Measurement of blood pressure after a 4-week diet, low in sodium. (time frame: after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2012.