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

Status unconfirmed · Phase 1

Conditions studied: Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Systemic Exertion Intolerance Disease (SEID), Postural Tachycardia Syndrome (POTS), Neurally Mediated Syncope (NMS)

In brief

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.

Key facts

Study ID

NCT02854683

Run by

New York Medical College

People needed

45

Starts

2016-02-01

Expected to finish

2021-12-01

Last updated by the study team

2021-06-10

Who can join

Age: 15 and older, up to 29. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• NewYork Medical College — Hawthorne, New York, United States

Full record on ClinicalTrials.gov

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