ISRCTN ISRCTN88789643
DOI https://doi.org/10.1186/ISRCTN88789643
Protocol serial number 060415/Z/00/Z and 069500/Z/02/Z
Sponsor Warwick Medical School (UK)
Funder The Wellcome Trust (UK) (grant refs: 060415 and 069500)
Submission date
15/08/2005
Registration date
02/09/2005
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Francesco P Cappuccio
Scientific

Clinical Sciences Research Institute
Warwick Medical School
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleReducing salt intake in West Africa
Study acronymKUMASI Study
Study objectivesTo reduce salt intake by health promotion and to relate the change in salt intake with the change in blood pressure (underlying hypothesis is that even a modest reduction in salt intake may cause a small reduction in population blood pressure).
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHypertension
InterventionRandomisation in clusters to Control Health Promotion Package or Intervention Health Promotion Package. The intervention cluster of villages will be exposed to a vigorous campaign of nutritional education to reduce salt intake.
Intervention typeOther
Primary outcome measure(s)

1. Urinary sodium excretion
2. Blood pressure

Key secondary outcome measure(s)

Iodine excretion

Completion date01/10/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration800
Key inclusion criteriaMen and women aged 40 to 75 years in 12 villages in Ashanti.
Key exclusion criteria1. Pregnant women
2. Very sick
Date of first enrolment01/04/2001
Date of final enrolment01/10/2003

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Ghana

Study participating centre

Clinical Sciences Research Institute
Coventry
CV2 2DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/01/2006 Yes No
Other publications 01/07/2002 Yes No
Other publications 01/05/2004 Yes No
Other publications 01/09/2005 Yes No
Other publications 01/09/2005 Yes No
Other publications 01/11/2005 Yes No
Other publications 01/12/2005 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

25/10/2022: Internal review.