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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201110000324321 Date registered: 2011/10/05
TRIAL DESCRIPTION
Public title Health effects of an improved cookstove intervention in Malawi: A Pilot Randomised Controlled Trial
Official scientific title Health effects of an improved cookstove intervention in Malawi: A Pilot Randomised Controlled Trial
Brief summary describing the background
and objectives of the trial
The study aims to explore trial feasibility issues while obtaining some preliminary data relating to the potential health impacts of an improved cookstove intervention in Malawi
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2011-10-10
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants) 100   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
P.07/11/1103 University of Malawi COMREC

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program in permuted blocks of 10 Sealed opaque envelopes Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Improved cook stove (Chitetezo) One cook stove One week Portable clay cook stove 50 Active
Control group None None None Continuation of usual cooking methods 50

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Non smoking women who cook using traditional stoves in Malawi Exposure to environmental tobacco smoke 14 Years 100 Years Female

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/09/26 University of Malawi College of Medicine REC
Ethics Committee Address
Street address City Postal code Country
College of Medicine, Private Bag 360, Chichiri Blantyre 3 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/07/13 Liverpool School of Tropical Medicine REC
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The main objective of this trial is to explore trial methodological issues relating to acceptability, recruitment, randomisation, intervention 1 week
Secondary Outcome Short-term impacts on ocular and respiratory symptoms, headache, backache and burns One week
Secondary Outcome Personal exposures to carbon monoxide and particulate matter, exhaled breath carbon monoxide, oxygen saturations One week

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Concern Universal Malawi 21 Link Road, Namiwawa Blantyre P.O. Box 1535 Malawi

FUNDING SOURCES
Name of source Street address City Postal code Country
Liverpool School of Tropical Medicine Research and Development Fund Pembroke Place Liverpool L3 5QA United Kingdom

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom University

COLLABORATORS
Name Street address City Postal code Country
Clioma Ltd Area 9 Plot 428, Private Bag 78 Lilongwe Malawi

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Kevin Mortimer kevin.mortimer@ liverpool.ac.uk 0044151 705 3373 00441515295888
Street address City Postal code Country Position / Affiliation
Liverpool School of Tropical Medicine, Pembroke Street Liverpool L3 5QA United Kingdom Senior Clinical Lecturer
Role Name Email Phone Fax
Public Enquiries Dr Kevin Mortimer kevin.mortimer@ liverpool.ac.uk 0044151 705 3373 00441515295888
Street address City Postal code Country Position / Affiliation
Liverpool School of Tropical Medicine, Pembroke Street Liverpool L3 5QA United Kingdom Senior Clinical Lecturer
Role Name Email Phone Fax
Scientific Enquiries Dr Kevin Mortimer kevin.mortimer@ liverpool.ac.uk 0044151 705 3373 00441515295888
Street address City Postal code Country Position / Affiliation
Liverpool School of Tropical Medicine, Pembroke Street