Salt and TH-17 in Healthy Human Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT02261688
• Date of registration: 07/10/2014
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Salt and TH-17 in Healthy Human Subjects
• Scientific title: Evaluation of the Influence of Salt Intake on TH17 Interleukin(IL)-17 Producing CD4+ Helper T Cells in Human Subjects
• Date of first enrolment: March 2014
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02261688
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Gordon Williams, MD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- We will seek normal, healthy volunteers age 18-45 years. Participants must be healthy,
BMI 18-25.

- We will first recruit male subjects into the pilot study to fully assess the
relationship between immune status and salt intake in the absence of hormonal
influences (ovulation and menstruation) to establish a baseline understanding before
embarking on such a study in women. We will study healthy women subjects in a
subsequent later study.

Subjects must have normal laboratory values for:

1. Complete blood count

2. Serum creatinine, sodium, potassium, glucose, liver enzymes

3. Urinalysis

4. Normal ECG

Exclusion Criteria:

We will exclude individuals with:

- Systolic blood pressure > 140 or < 90

- Diastolic blood pressure >90 or < 60

- Creatinine Clearance is abnormal (MDRD formula)

- Known DM, CHF, CAD, PVD, CVA, MI, or RAS.

- Known autoimmune disease (including thyroid disease, asthma, inflammatory bowel
disease, rheumatologic diseases)

- Known neurologic disease (i.e. MS)

- Steroid use (oral or inhaled, chronic or within the past 6 months)

- Significant concomitant medical illnesses (cancer, chronic active immunological
conditions, etc.)

- If spot Na > 30 after low salt diet

- Current excessive etoh (>10oz/etoh/week)

- Current use of recreational drugs

- Current smokers

- Abnormal labs

- Acute hospitalizations including surgery in the past 6 months

- Chronic use of non-steroidal anti-inflammatory or narcotic medications

- Evidence of ischemia or heart block on screening electrocardiogram (greater than type
I-second degree heart block, left bundle branch block, or

- ST-T wave changes in 2 or more contiguous leads)

- Subjects taking any prescription medications (with the exception of birth control
pills) or herbal medications will be excluded).

- Ingestion of probiotics within last 3 months

- Antibiotic use within last 3 months

- 1st degree relative with an onset of diabetes or hypertension before the age of 60

- 1st degree relative with autoimmune disease (including thyroid disease, asthma,
inflammatory bowel disease, rheumatologic diseases)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Salt Intake

Autoimmunity

Th17 Helper Immune Cells

Sodium Chloride

Intervention(s)

Dietary Supplement: Liberal salt diet

Dietary Supplement: Low salt diet + IV normal saline

Dietary Supplement: Low salt diet

Primary Outcome(s)

TH-17 levels [Time Frame: 5 days]

Secondary Outcome(s)

IL-17 levels [Time Frame: 5 days]

Secondary ID(s)

2013P002358

Source(s) of Monetary Support

Please refer to primary and secondary sponsors