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Healthy HumansNCT00345215

The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.

A study testing High Sodium Diet and Low Sodium Diet in people with Healthy Humans, run by Regional Hospital Holstebro at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to test the hypothesis that the function and/or regulation of aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is abnormal at high and low sodium intake Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Humans
What is being tested?
High Sodium Diet and Low Sodium Diet
How many people
26 participants
Where
1 siteDenmark
Study dates
May 2006to May 2007
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Caucasic men and women
  • Age 18-65 years
  • Body mass index less or equal to 30 Kg/m2

Who cannot join

  • Arterial hypertension
  • History or clinical signs of heart, brain, lung, kidney, malignant or endocrine organ disease.
  • Abnormal biochemical screening of the blood regarding: red and white cell count, B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumine, P- bilirubin, P-alanine aminotransferase, P- alkaline phosphatase, p-cholesterol and B-glucose.
  • Abnormal screening of the urine regarding: blood, albumine and glucose.
  • Alcohol or drug abuse
  • Drug use except oral contraceptives
Show all 11Show fewer
  • Smoking
  • Abnormal electrocardiogram
  • Blood donation within one month of the first examination day
  • Pregnancy
  • Unwillingness to participate

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Medical Research, Holstebro Hospital

    Holstebro, Holstebro, 7500

Other trials in Denmark

About this study

Official title: The Effect of High and Low Sodium Intake on Aquaporin-2 in Healthy Humans, During Basal Conditions and After Hypertonic Saline Infusion.

The aim of the study is to test the hypothesis that the function and/or regulation of aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is abnormal at high and low sodium intake

Conditions
Healthy Humans
Being tested
High Sodium Diet, Low Sodium Diet
Keywords
Urinary Aquaporin 2, High/low Sodium Diet, Fractional Sodium Excretion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Sodium DietBehavioural

    250-350 mmol

  • Low Sodium DietBehavioural

    25-35 mmol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. u-AQP-2

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  2. fractional sodium excretion

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  3. p-aldosterone

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary outcomes (6)

  1. u-pAQP-2

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  2. u-ENaC(alfa-beta-gamma)

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  3. CH20

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  4. ucAMP

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  5. uPGE2

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  6. GFR

    Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2006
  4. Study completionMay 2007

Resources

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
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345215
Sponsor's protocol ID
med.res.hos.2006.cc.01
Status last verified
Jun 2011
First submitted
24 Jun 2006
Last updated
28 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing High Sodium Diet and Low Sodium Diet in people with Healthy Humans, run by Regional Hospital Holstebro 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 3 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 28 Jun 2011. 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. 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?

u-AQP-2 (time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.). The study lists 3 primary outcomes in all. 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 NCT00345215.

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 28 Jun 2011.

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