The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects.

NCT06968182 | Completed DMC

• 2 other identifiers: RLS-1-20151-10-72-351-15
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Sodium; Renal Function; Blood Pressure

Keywords

sodium; Renal Handling

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment and at the end of the second examination day, aprox. 3-4 months

Study Arms (2)

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.

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.

Dietary Supplement: Sodium Chloride

Interventions

Sodium Chloride DIETARY_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.

High sodium; Low sodium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Pregnancy or lactation
• Blood donation within 1 month of the first investigation,
• Clinically relevant abnormal blood/urine sample or electrocardiography.
• Withdrawal criteria:
• Suspicion of poor compliance to study medication
• Withdrawal of signed concent.

Sponsors & Collaborators

• Frank Mose: lead
• Region MidtJylland Denmark: collaborator

Related Publications (1)

• 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.

  PMID: 40827100 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jesper N. Bech, professor

  University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Hospitalsparken 15, 7400 Herning, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Md. Ph.d.

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 18, 2016
• Primary Completion: January 13, 2017
• Study Completion: January 13, 2017
• Last Updated: May 25, 2025

Record last verified: 2025-05