Reducing Orthostatic Intolerance With Oral Rehydration in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients

NCT02854683 | Unknown Phase 1 DMC

• 2 other identifiers: L-11-531-1011R21NS094644-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia syndrome (POTS) in which standing results in an excessive heart rate, and neurally mediated hypotension (NMH) in which standing causes a fall in blood pressure and fainting. Intravenous fluids can alleviate these symptoms, but is difficult to administer; oral fluids fail to provide the same benefit. We would therefore like to test the effectiveness of an oral rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and sodium, to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare these results with healthy control subjects.

Conditions

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Systemic Exertion Intolerance Disease (SEID); Postural Tachycardia Syndrome (POTS); Neurally Mediated Syncope (NMS)

Keywords

Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME); Postural Tachycardia Syndrome (POTS); Neurally Mediated Syncope (NMS); Systemic Exertion Intolerance Disease (SEID); Orthostatic Intolerance (OI); Oral Rehydration Solution (ORS); Lower Body Negative Pressure (LBNP)

Outcome Measures

Primary Outcomes (1)

• To test whether 1 Liter volumes of intravenous or oral rehydration solution increase total blood volume and cardiac output, comparably improving the threshold for orthostatic intolerance

  We will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after completing an intravenous infusion of normal saline. Hematocrit will be measure every 10 minutes for changes in blood volume. On a second day, we will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after ingesting 1 liter of oral rehydration solution. Hematocrit will be measure every 10 minutes for changes in blood volume.

  1 week

Study Arms (2)

Normal Saline

EXPERIMENTAL

Subjects will receive 1 liter of intravenous normal saline over 1 hour and on an alternate day Subjects will drink ORS solution 1 liter total by mouth over 20 minutes.

Drug: Normal Saline

Oral rehydration solution

EXPERIMENTAL

Subjects will receive 1 liter of intravenous normal saline over 1 hour and on an alternate day Subjects will drink ORS solution 1 liter total by mouth over 20 minutes.

Dietary Supplement: Oral Rehydration Solution

Interventions

Normal Saline DRUG

1 liter of intravenous saline will be delivered over 1 hour

Also known as: NSS

Normal Saline

Oral Rehydration Solution DIETARY_SUPPLEMENT

1 liter of ORS solution given by mouth

Also known as: ORS

Oral rehydration solution

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both female and male participants are being studies
• Ages 15-29
• All subjects must fulfill criteria for Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) and include 15 with Neurally Mediated Syncope (NMS) and 15 with Postural Tachycardia Syndrome (POTS).
• ME/CFS patients with NMS will be cases with episodic symptoms of Orthostatic Intolerance (OI) associated with 3 or more episodes of abrupt loss of consciousness and postural tone within the last year (simple faint)
• ME/CFS patients with POTS will have chronic day to day symptoms of OI for at least 3 months. POTS will be confirmed by duplication of these symptoms per tilt table test
• Healthy volunteers will be included and free from any disease

You may not qualify if:

• all subjects will have normal physical exam and be free of all systemic disease
• no subjects will be taking neurally active or vasoactive medications. Any prior medications will be discontinued for at least 2 weeks.

Sponsors & Collaborators

• New York Medical College: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

NewYork Medical College

Hawthorne, New York, 10532, United States

Location

Related Links

• The Center for Hypotensioin

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Postural Orthostatic Tachycardia Syndrome; Syncope, Vasovagal; Orthostatic Intolerance; Osteoarthritis

Interventions

Saline Solution; World Health Organization oral rehydration solution; ORALIT

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marvin S. Medow, Ph.D.

  New York Medical Collete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 3, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

US (1)