China Salt Substitute and Stroke Study

NCT02092090 | Completed DMC

• 2 other identifiers: SSaSSGrant ID 1049417
• Study Type: interventional
• Target: 20,996
• Locations: 1 country
• Sites: 5

Brief Summary

The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.

Conditions

Stroke

Keywords

salt substitute; sodium reduction; stroke; cluster randomized trial; China

Outcome Measures

Primary Outcomes (1)

• Stroke

  The primary outcome will be stroke defined according to standard criteria on the basis of an acute disturbance of focal neurological function and resulting in death or symptoms lasting more than 24 hours. Imaging, clinical and laboratory data will be collected wherever possible.

  5 years

Secondary Outcomes (2)

• Total major vascular events

  5 years

• Total mortality

  5 years

Other Outcomes (4)

• Blood Pressure

  5 years

• Urinary sodium excretion

  5 years

• Urinary Potassium

  5 years

Study Arms (2)

Control

NO INTERVENTION

Dietary advice at baseline only

Dietary sodium reduction

EXPERIMENTAL

Dietary advice and reduced-sodium added-potassium salt substitute

Behavioral: Dietary sodium reduction

Interventions

Dietary sodium reduction BEHAVIORAL

Ongoing dietary advice and a supply of a reduced-sodium added-potassium salt substitute

Also known as: Reduced-sodium added-potassium salt substitute

Dietary sodium reduction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease history
• Prior stroke and/or
• Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure \>=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure\>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
• Ownership of a phone by the participant or a household member

You may not qualify if:

• Participant or family member is using a potassium-sparing diuretic
• Participant or family member is using a potassium supplement
• Participant or family member has serious renal impairment
• Participant or family member has other reason for concern about use of salt substitute
• Participant eats most meals outside the home
• Participant is not expected to live longer than 6 months from the date of assessment as estimated by the village doctor
• Another family member living in the same household has already been included in the study

Sponsors & Collaborators

• The George Institute: lead
• Peking University: collaborator
• Northwestern University: collaborator
• Imperial College London: collaborator
• China Medical University, China: collaborator
• Changzhi Medical College: collaborator
• Centers for Disease Control and Prevention, China: collaborator
• Ningxia Medical University: collaborator
• Xi'an Jiaotong University: collaborator

Study Sites (5)

Hebei Province Centre for Disease Control and Prevention

Shijiazhuang, Hebei, 71000, China

Location

China Medical Universtity

Shenyang, Liaoning, 110001, China

Location

Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Xi'an Jiaotong University

Xi'an, Shaanxi, 710049, China

Location

Changzhi Medical Colledge

Changzhi, Shanxi, 046000, China

Location

Related Publications (8)

• Zhang X, Yin X, Yap ML, Li Q, Huang L, Liu Y, Zhou B, Li Z, Zhao Y, Sun J, Yu Y, Yan LL, Wu Y, Neal B, Tian M. Effect of sodium-reduced potassium-enriched salt substitutes on stomach cancer: the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2025 Apr 23;23(1):236. doi: 10.1186/s12916-025-04068-0.

  PMID: 40264179 DERIVED

• Ding X, Zhang X, Huang L, Xiong S, Li Z, Zhao Y, Zhou B, Yin X, Xu B, Wu Y, Neal B, Tian M, Yan LL. Salt Substitution and Recurrent Stroke and Death: A Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 1;10(4):343-350. doi: 10.1001/jamacardio.2024.5417.

  PMID: 39908026 DERIVED

• Wang F, Pi Y, Zhao Y, Zhang Y, Zhou B, Li Z, Sun J, Yu Y, Tian M, Yang M, Huang L, Song H, Neal B, Kissock KR. Effect of salt substitution on fracture-a secondary analysis of the Salt Substitute and Stroke Study (SSaSS). BMC Med. 2024 Sep 4;22(1):366. doi: 10.1186/s12916-024-03586-7.

  PMID: 39232779 DERIVED

• Yu J, Arnott C, Li Q, Di Tanna GL, Tian M, Huang L, Yin X, Zhang X, Pearson SA, Labarthe DR, Elliott P, Yan LL, Zhou B, Wu Y, Neal B. Secondary Analysis of the Salt Substitute and Stroke Study (SSaSS): Effects of Potassium-Enriched Salt on Cardiac Outcomes. Hypertension. 2024 May;81(5):1031-1040. doi: 10.1161/HYPERTENSIONAHA.123.22410. Epub 2024 Mar 11.

  PMID: 38465623 DERIVED

• Haghdoost F, Gnanenthiran SR, Shan S, Kaistha P, Huang L, Tian M, Liu Y, Yin X, Zhang X, Hao Z, Wu Y, Di Tanna GL, Neal B, Rodgers A. The effect of salt substitution on frequency and severity of headache: results from the SSaSS cluster-randomised controlled trial of 20,995 participants. Eur J Clin Nutr. 2024 May;78(5):401-406. doi: 10.1038/s41430-024-01419-7. Epub 2024 Feb 24.

  PMID: 38402353 DERIVED

• Yin X, Paige E, Tian M, Li Q, Huang L, Yu J, Rodgers A, Elliott P, Wu Y, Neal B. The Proportion of Dietary Salt Replaced With Potassium-Enriched Salt in the SSaSS: Implications for Scale-Up. Hypertension. 2023 May;80(5):956-965. doi: 10.1161/HYPERTENSIONAHA.122.20115. Epub 2023 Jan 11.

  PMID: 36628969 DERIVED

• Neal B, Wu Y, Feng X, Zhang R, Zhang Y, Shi J, Zhang J, Tian M, Huang L, Li Z, Yu Y, Zhao Y, Zhou B, Sun J, Liu Y, Yin X, Hao Z, Yu J, Li KC, Zhang X, Duan P, Wang F, Ma B, Shi W, Di Tanna GL, Stepien S, Shan S, Pearson SA, Li N, Yan LL, Labarthe D, Elliott P. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med. 2021 Sep 16;385(12):1067-1077. doi: 10.1056/NEJMoa2105675. Epub 2021 Aug 29.

  PMID: 34459569 DERIVED

• Li KC, Tian M, Neal B, Huang L, Yu J, Liu Y, Yin X, Zhang X, Wu Y, Li N, Elliott P, Yan L, Labarthe D, Hao Z, Shi J, Feng X, Zhang J, Zhang Y, Zhang R, Zhou B, Li Z, Sun J, Zhao Y, Yu Y, Si L, Lung T. Protocol for the economic evaluation of the China Salt Substitute and Stroke Study (SSaSS). BMJ Open. 2021 Jul 20;11(7):e045929. doi: 10.1136/bmjopen-2020-045929.

  PMID: 34285006 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bruce C Neal, PhD

  The George Institute for Global Health, Australia

  PRINCIPAL INVESTIGATOR

• Yangfeng Wu, PhD

  The George Institute for Global Health at Peking University Health Science Centre

  PRINCIPAL INVESTIGATOR

• Darwin Labarthe, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Paul Elliott, PhD

  School of Public Health, Imperial College London

  PRINCIPAL INVESTIGATOR

• Lijing L Yan, PhD

  The George Institute for Global Health at Peking University Health Science Centre

  PRINCIPAL INVESTIGATOR

• Nicole Y Li, PhD

  The George Institute for Global Health, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 19, 2014
• Study Start: July 9, 2014
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (5)