Salt and TH-17 in Healthy Human Subjects

Stopped early · Not applicable

Conditions studied: Th17 Helper Immune Cells, Autoimmunity, Salt Intake, Sodium Chloride

In brief

The overall goal of this study is to evaluate the association between sodium and TH17 cells in human subjects. The subjects will have levels of TH-17 and various hormones measured on low salt diet, low salt diet with intravenous normal saline, and high salt diet.

Key facts

Study ID

NCT02261688

Run by

Brigham and Women's Hospital

People needed

9

Starts

2014-03-01

Expected to finish

2019-08-01

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Complete blood count
• Serum creatinine, sodium, potassium, glucose, liver enzymes
• Urinalysis
• Normal ECG

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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