Salt and TH-17 in Healthy Human Subjects

NCT02261688 | Terminated DMC

• 1 other identifier: 2013P002358
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Th17 Helper Immune Cells; Autoimmunity; Salt Intake; Sodium Chloride

Outcome Measures

Primary Outcomes (1)

• TH-17 levels

  5 days

Secondary Outcomes (1)

• IL-17 levels

  5 days

Study Arms (1)

Subjects in study

OTHER

All subjects in study are in a cross-over study with 3 interventions sequentially (low salt diet, low salt diet + IV normal saline, liberal salt diet)

Dietary Supplement: Low salt diet; Dietary Supplement: Low salt diet + IV normal saline; Dietary Supplement: Liberal salt diet

Interventions

Low salt diet DIETARY_SUPPLEMENT

Low salt diet, 10mmoL of sodium per day, for 6 days

Subjects in study

Low salt diet + IV normal saline DIETARY_SUPPLEMENT

Low salt diet, 10 mmoL of sodium per day, for 4 days with normal saline infusion x 12 hours per day for 200 mmoL of sodium chloride. Total daily sodium is 210 mmoL/day.

Subjects in study

Liberal salt diet DIETARY_SUPPLEMENT

Liberal salt diet targeting 200 mmoL of sodium per day x 7 days

Subjects in study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Diet, Sodium-Restricted; Saline Solution

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gordon Williams, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiovascular Endocrinology Section, Brigham and Women's Hospital

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

US (1)