50 Participants Needed

High Salt Diet for POTS

(CASA-POTS Trial)

SR
TS
Overseen ByTanya Siddiqui, MBBS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using fludrocortisone or have received IV saline in the last 2 months.

What data supports the effectiveness of the drug Sodium Chloride Capsules for POTS?

There is no direct evidence from the provided research articles that supports the effectiveness of Sodium Chloride Capsules specifically for POTS. However, sodium intake is known to affect blood pressure, and managing blood pressure is often a component of treating POTS.12345

Is a high salt diet generally safe for humans?

Research suggests that while high salt intake can increase blood pressure, it does not necessarily jeopardize blood pressure control in patients already on antihypertensive medication. However, high salt intake is associated with a higher risk of cardiovascular disease, so it should be consumed in moderation.16789

How does the drug Sodium Chloride Capsules differ from other treatments for POTS?

Sodium Chloride Capsules are unique for POTS as they involve increasing salt intake, which is contrary to typical advice for conditions like hypertension where reducing sodium is recommended. This approach aims to increase blood volume and improve symptoms, which is different from other treatments that might focus on heart rate or blood pressure control.15101112

What is the purpose of 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.

Research Team

SR

Satish R Raj

Principal Investigator

University of Calgary

Eligibility Criteria

The trial is for Canadian residents aged 18-60 with POTS, who experience a rapid heartbeat upon standing but don't have a drop in blood pressure. Participants must be able to visit the Calgary Autonomic Research Clinic and should not have orthostatic hypotension.

Inclusion Criteria

Ability to attend the Calgary Autonomic Research Clinic in Calgary
Resident of Canada
I feel better lying down due to chronic dizziness or faintness.
See 3 more

Exclusion Criteria

Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
Pregnant (self-reported)
Participants with somatization or severe anxiety symptoms will be excluded
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment - Moderate Dietary Salt Plus Additional Salt

Participants receive a moderate dietary salt plus additional salt diet for 6 weeks, including autonomic function testing and blood volume assessment

6 weeks
1 visit (in-person) at the end of the arm

Treatment - Moderate Dietary Salt Alone (Placebo)

Participants receive a moderate dietary salt alone diet for 6 weeks, including autonomic function testing and blood volume assessment

6 weeks
1 visit (in-person) at the end of the arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Sodium Chloride Capsules
Trial Overview This study tests if taking extra salt (sodium chloride capsules) helps manage POTS symptoms compared to placebo (microcrystalline cellulose capsules). It's a cross-over trial where participants switch between high salt and normal diets over three months, with lab evaluations.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Moderate Dietary Salt Plus Additional SaltExperimental Treatment1 Intervention
6 grams of salt in slow release capsules combined with 6 grams of salt in the diet.
Group II: Moderate Dietary Salt AlonePlacebo Group1 Intervention
6 grams of microcrystalline cellulose in slow release capsules combined with 6 grams of salt in the diet.

Sodium Chloride Capsules is already approved in Canada, United States, European Union for the following indications:

🇨🇦
Approved in Canada as Sodium Chloride for:
  • Postural Orthostatic Tachycardia Syndrome (POTS)
🇺🇸
Approved in United States as Sodium Chloride for:
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Vasovagal Syncope (VVS)
🇪🇺
Approved in European Union as Sodium Chloride for:
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Vasovagal Syncope (VVS)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Findings from Research

High sodium intake (over 6 g/day) is linked to an increased risk of cardiovascular disease (CVD), while very low intake (under 3 g/day) is also associated with higher risk, suggesting that both extremes of sodium consumption can be harmful.
The optimal sodium intake for minimizing CVD risk appears to be between 3-5 g/day, based on recent prospective cohort studies, but further randomized controlled trials are needed to confirm this optimal range.
Evidence relating sodium intake to blood pressure and CVD.O'Donnell, M., Mente, A., Yusuf, S.[2021]
Reducing daily sodium intake by 1840 mg could prevent approximately 11,550 cardiovascular disease events annually in Canada, highlighting the significant impact of dietary changes on heart health.
The study suggests that a sodium reduction from 1200 mg to 2400 mg per day could lead to a decrease in cardiovascular events ranging from 8300 to 16,800 per year, emphasizing the importance of sodium intake in managing cardiovascular risk.
Reducing dietary sodium and decreases in cardiovascular disease in Canada.Penz, ED., Joffres, MR., Campbell, NR.[2021]
Potassium supplementation significantly reduces blood pressure in hypertensive patients with high salt intake, showing a pooled reduction of -9.5 mmHg for systolic and -6.4 mmHg for diastolic pressure based on a meta-analysis of 10 studies.
The effectiveness of potassium treatment is influenced by salt intake levels, with patients on lower salt diets experiencing minimal benefits, suggesting that previous analyses may have underestimated potassium's potential in managing hypertension.
Potassium treatment for hypertension in patients with high salt intake: a meta-analysis.van Bommel, E., Cleophas, T.[2012]

References

Evidence relating sodium intake to blood pressure and CVD. [2021]
Reducing dietary sodium and decreases in cardiovascular disease in Canada. [2021]
Potassium treatment for hypertension in patients with high salt intake: a meta-analysis. [2012]
The effect of chloride-containing potassium supplements on chloride titrator estimates of dietary sodium intake. [2019]
Hemodynamic and endocrine changes associated with potassium supplementation in sodium-loaded hypertensives. [2016]
Increased dietary sodium chloride in patients treated with antihypertensive drugs. [2019]
Salt restriction for treatment of hypertension - current state and future directions. [2023]
Sodium Intake and Related Diseases 2.0. [2022]
Dietary Impact of Adding Potassium Chloride to Foods as a Sodium Reduction Technique. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Decreasing dietary sodium while following a self-selected potassium-rich diet reduces blood pressure. [2018]
Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure? [2016]
Unchanged central hemodynamics after six months of moderate sodium restriction with or without potassium supplement in essential hypertension. [2019]
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