Chronic Fatigue SyndromePhase 1NCT02854683
Reducing Orthostatic Intolerance With Oral Rehydration in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients
A Phase 1 study testing Normal Saline and Oral Rehydration Solution in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by New York Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Systemic Exertion Intolerance Disease (SEID)
- What is being tested?
- Normal Saline and Oral Rehydration Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Orthostatic Intolerance With Oral Rehydration in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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.
Read the detailed description
We and others have shown that a majority of younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), the inability to tolerate orthostatic stress such as prolonged standing. OI in ME/CFS comprises postural tachycardia syndrome (POTS) in which symptoms occur along with excessive upright heart rate, and neurally mediated hypotension (NMH) in which symptoms occur along with an upright fall in blood pressure. The causes of OI are diverse but are clearly initiated by postural contraction of central blood volume (BV) by gravitational translocation of 500-800 mL of blood from the upper to the lower body. Intravenous central BV expansion with isotonic saline is commonly and effectively used to reduce OI regardless of etiology, but has complications if used long term. Usual forms of oral hydration fail to provide similar benefit. Interestingly, a specific isotonic oral rehydration solution (ORS W.H.O. formula), making use of co-transport of glucose and sodium, has been shown to efficiently rehydrate cholera patients suggesting an ability to increase central BV rivaling intravenous fluids. Since the circulatory effects of saline or ORS BV expansion are incompletely understood, we propose to study the neurovascular physiology of fluid loading during orthostatic stress in ME/CFS patients with POTS or NMH, comparing results with healthy control subjects. We hypothesize that equal volumes of ORS is not inferior and may be superior to intravenous saline infusion in increasing intravascular and interstitial fluid volume and improving orthostatic tolerance. Using noninvasive measurements of heart rate and blood pressure by Finapres and oscillometry, cardiac output and peripheral arterial resistance by inert gas rebreathing, cerebral blood flow velocity by transcranial Doppler ultrasound, and regional fluid shifts by impedance and venous occlusion plethysmography, we have acquired preliminary data in ME/CFS patients with OI demonstrating superior restoration of orthostatic tolerance with ORS. We will recruit patients aged 15-29 years who have confirmed ME/CFS with OI, including 15 with NMH and 15 with POTS, and compare them to 15 healthy volunteer subjects. In Specific Aim 1 we will measure BV by Daxor iodinated albumin technique before orthostatic stress imposed by step-wise lower body negative pressure (LBNP) to measure the threshold for OI. Relative changes in BV using serial hematocrits in OI patients will be compared to data from control subjects similarly tested. In Specific Aim 2, all subjects will be randomized to receive saline or ORS in a cross over study. On one day, total BV and neurovascular properties will be measured in patients and control subjects before and 1 hour after completing one liter administration of intravenous normal saline infusion or ORS. On another day (separated by 1 week), we will repeat measurements using the other hydration route. We will perform LBNP on each day following saline or ORS to determine whether orthostatic intolerance and circulatory physiology are improved similarly with equivolumic IV saline or ORS hydration.
- Conditions
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Systemic Exertion Intolerance Disease (SEID), Postural Tachycardia Syndrome (POTS), Neurally Mediated Syncope (NMS)
- Being tested
- Normal Saline, Oral Rehydration Solution
- 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)
- Medical subject headings
- Fatigue Syndrome, Chronic, Postural Orthostatic Tachycardia Syndrome, Syncope, Vasovagal, Orthostatic Intolerance, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called NSS
1 liter of intravenous saline will be delivered over 1 hour
Oral Rehydration SolutionDietary supplement
Also called ORS
1 liter of ORS solution given by mouth
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oral Rehydration Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Marvin S. Medow, Ph.D., Principal investigator, New York Medical Collete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854683
- Sponsor's protocol ID
- L-11-531-101
- Other IDs
- 1R21NS094644-01
- Status last verified
- Jun 2021
- First submitted
- 29 Jul 2016
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Orthostatic Intolerance With Oral Rehydration in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT02854683
- Acronym / sponsor ID
- L-11-531-101
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We and others have shown that a majority of younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), the inability to tolerate orthostatic stress such as prolonged standing. OI in ME/CFS comprises postural tachycardia syndrome (POTS) in which symptoms occur along with excessive upright heart rate, and neurally mediated hypotension (NMH) in which symptoms occur along with an upright fall in blood pressure. The causes of OI are diverse but are clearly initiated by postural contraction of central blood volume (BV) by gravitational translocation of 500-800 mL of blood from the upper to the lower body. Intravenous central BV expansion with isotonic saline is commonly and effectively used to reduce OI regardless of etiology, but has complications if used long term. Usual forms of oral hydration fail to provide similar benefit. Interestingly, a specific isotonic oral rehydration solution (ORS W.H.O. formula), making use of co-transport of glucose and sodium, has been shown to efficiently rehydrate cholera patients suggesting an ability to increase central BV rivaling intravenous fluids. Since the circulatory effects of saline or ORS BV expansion are incompletely understood, we propose to study the neurovascular physiology of fluid loading during orthostatic stress in ME/CFS patients with POTS or NMH, comparing results with healthy control subjects. We hypothesize that equal volumes of ORS is not inferior and may be superior to intravenous saline infusion in increasing intravascular and interstitial fluid volume and improving orthostatic tolerance. Using noninvasive measurements of heart rate and blood pressure by Finapres and oscillometry, cardiac output and peripheral arterial resistance by inert gas rebreathing, cerebral blood flow velocity by transcranial Doppler ultrasound, and regional fluid shifts by impedance and venous occlusion plethysmography, we have acquired preliminary data in ME/CFS patients with OI demonstrating superior restoration of orthostatic tolerance with ORS. We will recruit patients aged 15-29 years who have confirmed ME/CFS with OI, including 15 with NMH and 15 with POTS, and compare them to 15 healthy volunteer subjects. In Specific Aim 1 we will measure BV by Daxor iodinated albumin technique before orthostatic stress imposed by step-wise lower body negative pressure (LBNP) to measure the threshold for OI. Relative changes in BV using serial hematocrits in OI patients will be compared to data from control subjects similarly tested. In Specific Aim 2, all subjects will be randomized to receive saline or ORS in a cross over study. On one day, total BV and neurovascular properties will be measured in patients and control subjects before and 1 hour after completing one liter administration of intravenous normal saline infusion or ORS. On another day (separated by 1 week), we will repeat measurements using the other hydration route. We will perform LBNP on each day following saline or ORS to determine whether orthostatic intolerance and circulatory physiology are improved similarly with equivolumic IV saline or ORS hydration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Drug: Normal SalineSubjects 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. |
| Oral rehydration solution | Experimental | Dietary Supplement: Oral Rehydration SolutionSubjects 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. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineAlso: NSS1 liter of intravenous saline will be delivered over 1 hour | Drug | Normal Saline |
| Oral Rehydration SolutionAlso: ORS1 liter of ORS solution given by mouth | Dietary supplement | Oral rehydration solution |
Primary outcome
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
Time frame: 1 week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin S. Medow, Ph.D. principal investigator
New York Medical Collete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Normal Saline and Oral Rehydration Solution in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.