Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)NCT05649631
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
A study testing Sodium in people with Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- What is being tested?
- Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Dec 2022
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years;
- diagnosed as PA by SIT;
- no lateralization of aldosterone secretion during AVS;
- serum potassium ≥ 2.8 mmol/L after the stage I.
Who cannot join
- Impaired renal function (Ccr<60 ml/min);
- Impaired liver function (ALT, AST > 2.5 times upper limit of normal);
- Patients with heart failure (NYHA≥ class 3 or EF < 50%);
- Patients with stroke or acute infarction in the last 6 months;
- Patients who are pregnant or breastfeeding;
- Patients who cannot tolerate dietary arrangements;
- Patients with history of malignant tumors in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
- Being tested
- Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SodiumDietary supplement
50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups.
| Study group | Role | What they receive |
|---|---|---|
| Normal sodium diet(100mmol/d) | Experimental | Not described Receives: Dietary Supplement: Sodium |
| Low sodium diet(50mmol/d) | Experimental | Not described Receives: Dietary Supplement: Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
Measured: 2 weeks
Secondary outcomes (1)
The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649631
- Sponsor's protocol ID
- Ruijin-2020-294
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou L, Jiang Y, Zhang C, Su T, Jiang L, Zhou W, Zhong X, Wu L, Wang W. Effects of a low-sodium diet in patients with idiopathic hyperaldosteronism: a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 19;14:1124479. doi: 10.3389/fendo.2023.1124479. eCollection 2023.
PubMed 37152926
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
- ClinicalTrials.gov ID
- NCT05649631
- Acronym / sponsor ID
- Ruijin-2020-294
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Dec 2022 (actual)
- 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.
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sodium diet(100mmol/d) | Experimental | Dietary Supplement: Sodium |
| Low sodium diet(50mmol/d) | Experimental | Dietary Supplement: Sodium |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years;
- diagnosed as PA by SIT;
- no lateralization of aldosterone secretion during AVS;
- serum potassium ≥ 2.8 mmol/L after the stage I.
Key exclusion criteria (7 listed)
- Impaired renal function (Ccr<60 ml/min);
- Impaired liver function (ALT, AST > 2.5 times upper limit of normal);
- Patients with heart failure (NYHA≥ class 3 or EF < 50%);
- Patients with stroke or acute infarction in the last 6 months;
- Patients who are pregnant or breastfeeding;
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 |
|---|---|---|
| Sodium50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups. | Dietary supplement | Low sodium diet(50mmol/d), Normal sodium diet(100mmol/d) |
Primary outcome
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
Time frame: 2 weeks
1 secondary outcome
The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 37152926Zhou L, Jiang Y, Zhang C, Su T, Jiang L, Zhou W, Zhong X, Wu L, Wang W. Effects of a low-sodium diet in patients with idiopathic hyperaldosteronism: a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 19;14:1124479. doi: 10.3389/fendo.2023.1124479. eCollection 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium in people with Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Dec 2022. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649631, which also lists 1 linked publication.
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 14 Dec 2022.