Condition category
Circulatory System
Date applied
15/08/2005
Date assigned
02/09/2005
Last edited
22/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www2.warwick.ac.uk/fac/med/clinsci/research/cvme/kumasi

Contact information

Type

Scientific

Primary contact

Prof Francesco P Cappuccio

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

060415/Z/00/Z and 069500/Z/02/Z

Study information

Scientific title

Acronym

KUMASI Study

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Hypertension

Intervention

Randomisation 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Urinary sodium excretion
2. Blood pressure

Secondary outcome measures

Iodine excretion

Overall trial start date

01/04/2001

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women aged 40 to 75 years in 12 villages in Ashanti.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Pregnant women
2. Very sick

Recruitment start date

01/04/2001

Recruitment end date

01/10/2003

Locations

Countries of recruitment

Ghana

Trial participating centre

Clinical Sciences Research Institute
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Warwick Medical School (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant refs: 060415 and 069500)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/16049517
2. http://www.ncbi.nlm.nih.gov/pubmed/16093908
3. http://www.ncbi.nlm.nih.gov/pubmed/16279134
4. http://www.ncbi.nlm.nih.gov/pubmed/15720047
5. http://www.ncbi.nlm.nih.gov/pubmed/15037552
6. http://www.ncbi.nlm.nih.gov/pubmed/12096149
7. http://www.ncbi.nlm.nih.gov/pubmed/16433927

Publication citations

  1. Harries TH, Twumasi-Abosi V, Plange-Rhule J, Cappuccio FP, Hypertension management in Kumasi: barriers and prejudice?, J Hum Hypertens, 2005, 19, 12, 975-977, doi: 10.1038/sj.jhh.1001920.

  2. Kerry SM, Micah FB, Plange-Rhule J, Eastwood JB, Cappuccio FP, Blood pressure and body mass index in lean rural and semi-urban subjects in West Africa., J. Hypertens., 2005, 23, 9, 1645-1651.

  3. Kerry SM, Cappuccio FP, Emmett L, Plange-Rhule J, Eastwood JB, Reducing selection bias in a cluster randomized trial in West African villages., Clin Trials, 2005, 2, 2, 125-129.

  4. Kerry SM, Emmett L, Micah FB, Martin-Peprah R, Antwi S, Phillips RO, Plange-Rhule J, Eastwood JB, Cappuccio FP, Rural and semi-urban differences in salt intake, and its dietary sources, in Ashanti, West Africa., Ethn Dis, 2005, 15, 1, 33-39.

  5. Cappuccio FP, Micah FB, Emmett L, Kerry SM, Antwi S, Martin-Peprah R, Phillips RO, Plange-Rhule J, Eastwood JB, Prevalence, detection, management, and control of hypertension in Ashanti, West Africa., Hypertension, 2004, 43, 5, 1017-1022, doi: 10.1161/01.HYP.0000126176.03319.d8.

  6. Plange-Rhule J, Cappuccio FP, Emmett L, Kerry SM, Edmundson AR, Acheampong D, Eastwood JB, A community study of health promotion in rural West Africa: details of a household survey and population census., QJM, 2002, 95, 7, 445-450.

  7. Cappuccio FP, Kerry SM, Micah FB, Plange-Rhule J, Eastwood JB, A community programme to reduce salt intake and blood pressure in Ghana [ISRCTN88789643]., BMC Public Health, 2006, 6, 13, doi: 10.1186/1471-2458-6-13.

Additional files

Editorial Notes