SodiumEGNANCT06968182
The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects.
A study testing Sodium Chloride in people with Sodium and Renal Function, run by Frank Mose.
Trial summary
The study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium, Renal Function, Blood Pressure
- What is being tested?
- Sodium Chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2016to 13 Jan 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both gender
- Age 18-50 years,
- BMI 18.5-30.0 kg/m2,
- Signed concent.
- Fertile women with safe contraception during the whole examination period.
Who cannot join
- Alcohol consumption > 7 drinks per week for women and, > 14 drinks per week for men.
- Smoking,
- Substance abuse
- Current use of medicine except contraception,
- Office BP > 140/90
- History or signs of clinically relevant kidney, heart, liver, lung, neurological, or endocrine diseases, neoplastic disorders,
Show all 13Show fewer
- Pregnancy or lactation
- Blood donation within 1 month of the first investigation,
- Clinically relevant abnormal blood/urine sample or electrocardiography.
- Withdrawal criteria:
- Development of exclusion criteria
- Suspicion of poor compliance to study medication
- Withdrawal of signed concent.
About this study
Official title: The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study
The study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. After the treatment the subjects went to an examination day. With 1 L isotonic sodium chlorid intravenous in 25 minutes, the subjects were further sodium and volume loaded. Change in salt blood test (SaBT), syndecan-1(syn-1) and heparan sulfate (HS), brachial and central blood pressure (BP), pulse wave velocity (PWV) and augmentation index (AIx) were measured. Baseline blood samples were taken before the treatment periods
Read the detailed description
Background: The endothelium is lined with endothelial glycocalyx (EG). EG protects the endothelium and functions as a barrier between blood and endothelium. Due to negative charges EG has a strong ability to buffer sodium. In vitro studies indicate that sodium overload can damage the EG and reduce the sodium buffer capacity. This could cause endothelial dysfunction and might lead to cardiovascular disease. EG can be measured by the erythrocyte salt sensitivity (ESS) and shedding of glycocalyx.
Purpose: The investigators aimed to examine the effect of dietary sodium balance on EG in healthy subjects.
Methods: In a double blinded, randomized, placebo controlled cross over study, 27 healthy subjects received a four days sodium reduced diet and treatment with NaCl or placebo in randomized order. Afterwards the subjects were further sodium and volume loaded with 1 L isotonic NaCl intravenously. Changes in ESS and blood pressure were measured.
- Conditions
- Sodium, Renal Function, Blood Pressure
- Being tested
- Sodium Chloride
- Keywords
- sodium, Renal Handling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ChlorideDietary supplement
During the examination day after a baseline period, from 11.00 AM to 11.30 AM, a sustained infusion of 1 L isotonic NaCl, was administered.
| Study group | Role | What they receive |
|---|---|---|
| High sodium | Active comparator | During the high sodium period, the subjects received 200 mmol sodium in tablets. The standardized sodium reduced diet contained 100 mmol sodium. Receives: Dietary Supplement: Sodium Chloride |
| Low sodium | Placebo comparator | During the low sodium period, the subjects received the placebo tablets contained 86 mg of potato starch and 85 mg lactose monohydrate. The standardized sodium reduced diet contained 100 mmol sodium. Receives: Dietary Supplement: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythrocyte salt sensitivity (ESS)
eGC is in dynamic equilibrium between biosynthesis of new components and release of "old". This is called shedding and the protein components can be measured in the plasma. Shedding is increased in e.g. sepsis, ischemia, kidney failure and severe bleeding {{38 Mulivor,A.W. 2004; 36 Salmon, Andrew H J AH 2012; 48 Sillesen,M. 2014; 49 Nelson,A. 2008; 50 Steppan,J. 2011}}{{35 Nieuwdorp,M. 2005}}.
The erythrocytes (RBC) also posses a glycocalyx-layer. Intact glycocalyx of both endothelium and erythrocytes is important for maintenance of electrostatic forces and frictionless passage of the RBC through the capillaries{{20 Oberleithner,H. 2013; 26 Oberleithner,H. 2012; 7 Oberleithner,H. 2015}} Deterioration of eGC affect the RBC, and the surface of the RBC becomes a mirror image of the properties of eGC{{20 Oberleithner,H. 2013; 8 Oberleithner,H. 2014}}.
Change in the RBC membrane can be demonstrated by a "salt-blood test-mini"{{18 Oberleithner,H. 2013; 99 Oberleithner,H. 2016}}. This is an
Measured: From enrollment and at the end of the second examination day, aprox. 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start18 May 2016
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
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 SodiumStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Design The study was conducted as a randomized, double-blinded, placebo-controlled, crossover trial. Subjects received a four days standardized and sodium reduced diet and NaCl tablets or placebo in random order. Each treatment period was followed by an examination day. The examination days were separated by a wash-out period of at least three weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Mose
- Sponsor type
- University, hospital or other
- Collaborators
- Region MidtJylland Denmark
- Responsible party
- Sponsor-investigator, Frank Mose, Region MidtJylland Denmark
- Investigators
- Jesper N. Bech, professor, Study director, University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Hospitalsparken 15, 7400 Herning, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968182
- Sponsor's protocol ID
- RLS-1-2015
- Other IDs
- 1-10-72-351-15
- Acronym
- EGNA
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ostergaard AM, Sonderbaek RL, Vrist MH, Rosenbaek JB, Mose FH, Bech JN. Effect of sodium balance on levels of nitrates in healthy subjects: Posthoc analysis of a randomized, double-blinded, placebo-controlled, crossover study. Physiol Rep. 2025 Aug;13(16):e70512. doi: 10.14814/phy2.70512.
PubMed 40827100
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study
- ClinicalTrials.gov ID
- NCT06968182
- Acronym / sponsor ID
- EGNA / RLS-1-2015
- Conditions
- Sodium, Renal Function, Blood Pressure
- Keywords
- sodium, Renal Handling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Frank MoseUniversity, hospital or other
- Collaborators
- Region MidtJylland Denmark
- Study start
- 18 May 2016 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 13 May 2025 (actual)
- 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.
The study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. After the treatment the subjects went to an examination day. With 1 L isotonic sodium chlorid intravenous in 25 minutes, the subjects were further sodium and volume loaded. Change in salt blood test (SaBT), syndecan-1(syn-1) and heparan sulfate (HS), brachial and central blood pressure (BP), pulse wave velocity (PWV) and augmentation index (AIx) were measured. Baseline blood samples were taken before the treatment periods
Detailed description
Background: The endothelium is lined with endothelial glycocalyx (EG). EG protects the endothelium and functions as a barrier between blood and endothelium. Due to negative charges EG has a strong ability to buffer sodium. In vitro studies indicate that sodium overload can damage the EG and reduce the sodium buffer capacity. This could cause endothelial dysfunction and might lead to cardiovascular disease. EG can be measured by the erythrocyte salt sensitivity (ESS) and shedding of glycocalyx.
Purpose: The investigators aimed to examine the effect of dietary sodium balance on EG in healthy subjects.
Methods: In a double blinded, randomized, placebo controlled cross over study, 27 healthy subjects received a four days sodium reduced diet and treatment with NaCl or placebo in randomized order. Afterwards the subjects were further sodium and volume loaded with 1 L isotonic NaCl intravenously. Changes in ESS and blood pressure were measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Design The study was conducted as a randomized, double-blinded, placebo-controlled, crossover trial. Subjects received a four days standardized and sodium reduced diet and NaCl tablets or placebo in random order. Each treatment period was followed by an examination day. The examination days were separated by a wash-out period of at least three weeks.
| Arm | Type | Receives |
|---|---|---|
| High sodium | Active comparator | Dietary Supplement: Sodium ChlorideDuring the high sodium period, the subjects received 200 mmol sodium in tablets. The standardized sodium reduced diet contained 100 mmol sodium. |
| Low sodium | Placebo comparator | Dietary Supplement: Sodium ChlorideDuring the low sodium period, the subjects received the placebo tablets contained 86 mg of potato starch and 85 mg lactose monohydrate. The standardized sodium reduced diet contained 100 mmol sodium. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender
- Age 18-50 years,
- BMI 18.5-30.0 kg/m2,
- Signed concent.
- Fertile women with safe contraception during the whole examination period.
Key exclusion criteria (13 listed)
- Alcohol consumption > 7 drinks per week for women and, > 14 drinks per week for men.
- Smoking,
- Substance abuse
- Current use of medicine except contraception,
- Office BP > 140/90
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 |
|---|---|---|
| Sodium ChlorideDuring the examination day after a baseline period, from 11.00 AM to 11.30 AM, a sustained infusion of 1 L isotonic NaCl, was administered. | Dietary supplement | High sodium, Low sodium |
Primary outcome
erythrocyte salt sensitivity (ESS)
Time frame: From enrollment and at the end of the second examination day, aprox. 3-4 months
eGC is in dynamic equilibrium between biosynthesis of new components and release of "old". This is called shedding and the protein components can be measured in the plasma. Shedding is increased in e.g. sepsis, ischemia, kidney failure and severe bleeding {{38 Mulivor,A.W. 2004; 36 Salmon, Andrew H J AH 2012; 48 Sillesen,M. 2014; 49 Nelson,A. 2008; 50 Steppan,J. 2011}}{{35 Nieuwdorp,M. 2005}}. The erythrocytes (RBC) also posses a glycocalyx-layer. Intact glycocalyx of both endothelium and erythrocytes is important for maintenance of electrostatic forces and frictionless passage of the RBC through the capillaries{{20 Oberleithner,H. 2013; 26 Oberleithner,H. 2012; 7 Oberleithner,H. 2015}} Deterioration of eGC affect the RBC, and the surface of the RBC becomes a mirror image of the properties of eGC{{20 Oberleithner,H. 2013; 8 Oberleithner,H. 2014}}. Change in the RBC membrane can be demonstrated by a "salt-blood test-mini"{{18 Oberleithner,H. 2013; 99 Oberleithner,H. 2016}}. This is an
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 25 May 2025.
- Derived from this study: PubMed 40827100Ostergaard AM, Sonderbaek RL, Vrist MH, Rosenbaek JB, Mose FH, Bech JN. Effect of sodium balance on levels of nitrates in healthy subjects: Posthoc analysis of a randomized, double-blinded, placebo-controlled, crossover study. Physiol Rep. 2025 Aug;13(16):e70512. doi: 10.14814/phy2.70512.
- Individual participant dataSharing planned: Undecided
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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.
Jesper N. Bech, professor study director
University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Hospitalsparken 15, 7400 Herning, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Chloride in people with Sodium and Renal Function, run by Frank Mose.
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 5 inclusion and 13 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
erythrocyte salt sensitivity (ESS) (time frame: From enrollment and at the end of the second examination day, aprox. 3-4 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 NCT06968182, 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 25 May 2025.