Testing Sodium Chloride with Microcystalline Cellulose against a placebo for postural orthostatic tachycardia syndrome
Official title: CAlgary SAlt for POTS
CAlgary SAlt for Postural Orthostatic Tachycardia Syndrome Study
- 2 groups
- One site, in Calgary
- Recruiting
Interventions
- Other intervention
Sodium Chloride Capsules
Table salt in slow release capsules.
- Other intervention
Microcystalline Cellulose Capsules
Microcrystalline Cellulose Capsules (Placebo)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 18-60 years old.
- +Physician Diagnosis of POTS as defined by the CCS Consensus Statement and as follows:
- +Sustained, excessive orthostatic tachycardia ≥ 30 bpm within 10 minutes standing.
- +Absence of orthostatic hypotension (\>20/10 mmHg decrease) within 3 minutes standing.
- +Chronic orthostatic symptoms that improve with recumbence.
- +Ability to attend the Calgary Autonomic Research Clinic in Calgary.
- +Resident of Canada
Exclusion
- −Overt cause for postural tachycardia (i.e., acute dehydration, thyroid disease)
- −Participants with somatization or severe anxiety symptoms will be excluded
- −Underlying causes of tachycardia including acute hypovolemia, endocrinopathy, anemia, anxiety, medication effects, recreational drug effects, and prolonged bedrest.
- −Other factors which in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion would prevent the participant from completing the protocolProtocolThe detailed plan a study must follow.Read more →, including poor compliance during previous studies
- −Fludrocortisone use (due to effects on renal Na+ handling)
- −Patients who have received IV saline in the 2 months preceding the study or who plan to receive it during the course of the study
- −Pregnant (self-reported)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Sodium Chloride Capsules.
Registry label: A: Moderate Dietary Salt Plus Additional Salt
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Microcystalline Cellulose Capsules.
Registry label: B: Moderate Dietary Salt Alone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 60 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 10 Minutes.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Upright Heart Rate — measured over 10 Minutes.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05924646 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Sodium Chloride CapsulesDietary supplement
Table salt in slow release capsules.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Microcystalline Cellulose CapsulesOther
Microcrystalline Cellulose Capsules (Placebo)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 60 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 60 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 10 Minutes.
The study as a whole is currently expected to finish around 2028-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Many patients with postural orthostatic tachycardia syndrome (POTS) have decreased plasma volume. Current POTS guidelines recommend \~10 g of salt and 2-3 L of fluid per day. Despite this recommendation, there is no long term data evaluating the use of salt in POTS. This randomized, placebo-controlled cross-over trial will evaluate a high salt diet, compared to a normal salt diet over a period of 3 months. Participants will complete 3 in lab evaluations including autonomic function testing, tilt table testing, blood volume and urine sodium evaluation, plasma catecholamine measurements and and cytokine measurements.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.