A Bengali Dietary Salt Study to Control Blood Pressure - Full Text View

Sponsors and Collaborators:	Barts & The London NHS Trust St. Bartholomew's Hospital
Information provided by:	Barts & The London NHS Trust
ClinicalTrials.gov Identifier:	NCT00702312

Purpose

The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.

Condition	Intervention	Phase
Hypertension	Behavioral: Low-salt educational programme	Phase III

MedlinePlus related topics: Dietary Sodium High Blood Pressure

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Method Study of a Low-Salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:

Reduction in blood pressure [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in dietary salt intake [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Study group that will attend low-salt educational programme	Behavioral: Low-salt educational programme Subjects will attend a health promotion cooking programme and receive written tailored low-salt Bengali educational tool. This tool has been developed specifically for this population group from Phase 1 and 2 study.
2: No Intervention Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.

Detailed Description:

We conducted an exploratory study initially to learn about the East London Bangladeshi (ELB) kidney patients salt intake. Furthermore, we assessed their educational needs to inform the development and implementation of an educational programme to reduce dietary salt intake in line with the Department of Health recommendations for a good blood pressure control. The educational programme will be tested in a randomized controlled trial. We are interested in salt because studies have shown that salt is one of the causes of high blood pressure. Scientific studies have also shown that the longer a person has high blood pressure the more the damage to the kidneys.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult Bengali kidney disease hypertensive patients

Exclusion Criteria:

Non-hypertensive Bengali patients and those on dialysis therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702312

Contacts

Contact: Ione Ashurst, BSc, MSc

020 7377 7000 ext 3340

ione.ashurst@bartsandthelondon.nhs.uk

Locations

United Kingdom
The Royal London Hospital	Recruiting
London, United Kingdom, E1 1BB
Principal Investigator: Ione Ashurst, BSc, MSc

Sponsors and Collaborators

Barts & The London NHS Trust

St. Bartholomew's Hospital

Investigators

Principal Investigator:

Ione Ashurst, BSc, MSc

Barts and The London NHS Trust

More Information

Responsible Party:	Barts and The London NHS Trust ( Ione Ashurst )
Study ID Numbers:	07/Q0605/13
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702312
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Barts & The London NHS Trust:

Blood pressure

Study placed in the following topic categories:

Renal Insufficiency, Chronic
Vascular Diseases
Kidney Failure, Chronic
Kidney Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009