Evidence map›Paper›PMID 35247964›Full record

Trial reportBMC nephrology2022

Efficacy and safety of a low-sodium diet and spironolactone in patients with stage 1-3a chronic kidney disease: a pilot study.

Hongmei Zhang, Bin Zhu, Liyang Chang, Xingxing Ye, Rongrong Tian, Luchen He, Dongrong Yu, Hongyu Chen, Yongjun Wang

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Hongmei ZhangDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China. hzzhanghongmei@163.com.ORCID 0000-0002-1839-9430
Bin ZhuDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Liyang ChangDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Xingxing YeDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Rongrong TianDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Luchen HeDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Dongrong YuDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Hongyu ChenDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Yongjun WangDepartment of Nephrology, Hangzhou TCM Hospital Affiliated to  Zhejiang Chinese Medical University, 453 Tiyuchang Road, Hangzhou, 310007, China.
Zhejiang Chinese Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExcessive salt intake is associated with the deterioration of chronic kidney disease (CKD). Aldosterone is also known as an independent risk factor for kidney injury. Dietary sodium intake acts as a main stimulator in aldosterone-mediated kidney injury. Hence, this study aimed to further investigate the renal protective effects and safety of a low-sodium diet in combination with spironolactone (SPL) in stage 1-3a CKD.

methodsThis single-center, SPL-blinded randomized controlled trial recruited patients with stage 1-3a CKD, randomized into three groups, low-sodium (3 g/d salt) + placebo, medium-sodium (5 g/d salt) + SPL, and low-sodium (3 g/d salt) + SPL. Patients received 12 weeks of intervention. The primary and secondary endpoints were 24-h urine protein and estimated glomerular filtration rate (eGFR) at the end of the intervention, respectively.

resultsA total of 74 patients were analyzed eventually. Significantly decreased 24-h urine protein was found in all three groups, from 0.37 to 0.23 g/d (P = 0.004) in the low-sodium+placebo group, from 0.44 to 0.29 g/d (P = 0.020) in the medium-sodium+SPL group, and from 0.35 to 0.31 g/d (P = 0.013) in the low-sodium +SPL group. There were no significant differences among the three groups in 24-h urine protein amount change after intervention from pre-treatment values (P = 0.760, ITT set). The results of the 24-h urine protein by using PP set analysis was similar to the ITT set. No significant differences in eGFR, nutritional, metabolic, inflammatory, and other biomarkers were observed across all three groups (P > 0.05). No safety signal was observed.

conclusionNo additional benefit was observed when SPL was prescribed to patients already on a low-sodium diet (3.0 g/d). Still, small doses of SPL may benefit patients with poor sodium restriction. A combination of short-term low-dose SPL and ARB is safe for patients with stage 1-3a CKD, but blood potassium must be regularly monitored.

trial registrationName of the registry: Chinese clinical trial registry. TRIAL REGISTRATION NUMBER: ChiCTR1900026991. Date of registration: Retrospectively registered 28 October 2019. URL of trial registry record: http://www.chictr.org.cn/searchproj.aspx?title=&officialname=&subjectid=&secondaryid=&applier=&studyleader=ðicalcommitteesanction=&spo.

Indexed as

Renal Insufficiency, ChronicSpironolactoneAldosteroneAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsDiet, Sodium-RestrictedFemaleHumansMalePilot ProjectsSodiumAldosteroneAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsSodiumSpironolactoneChronic kidney diseaseLow-sodium dietMineralocorticoid receptor antagonistSafetySpironolactone

Identifiers

PMID35247964
PMCPMC8897863
OpenAlexW4221052725

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.