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: pactr.samrc.ac.za
Trial no.: PACTR201512001320339 Date of Approval: 26/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of Water Contamination and Tanks Shock Chlorination in a Sudanese Refugees Camp: A Randomized Controlled Trial
Official scientific title Assessment of Water Contamination and Tanks Shock Chlorination in a Sudanese Refugees Camp: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The global prevalence of waterborne diseases in developing countries is about 80% of total illnesses (Platt, Vetleseter & Peterson, 1996). In Africa, most of the health problems which it faces are water-related, e.g. malaria, typhoid, schistosomiasis, diarrhoeal diseases, cholera, and dysenteries (Kuitcha et al. and Ndjama et al., 2008). This is even worse in Sudan, an arid area, where limited access to adequate water remains a major environmental hazard to public health (Bannaga and Pickford, 1978). As a result, the burden of diarrhoeal diseases is increasing. The last health status report issued by National Ministry of Health demonstrated an increasing trend in cases of diarhoea over the last three years by the following figures 30156, 56902, and 73987, respectively (Yousif, et al., 2014, p. 89). Last year, prevalence of diarrhea was 18% in the whole country, whilst, this was much higher in Khartoum (39%) making it the leading state with 25569 cases and 191 deaths (Yousif, et al., 2014, p. 67). World Health Organization (WHO) defines diarrheoa as three or more episodes of loose motions a day (Baqui, et al., 1991). For practical purposes, such diseases are best described based on certain criteria that fits screening purposes of wide scale studies. For instance, our cases were defined based on Hellard, et al. (2001) criteria of Highly credible gastroenteritis (HCG). Presence of the following in a 24-hr duration: ¿2 loose stools; ¿2 episodes of vomiting; 1 loose stool plus nausea, vomiting, or abdominal pain; and single episode of vomiting accompanying nausea or abdominal pain. To the best of our knowledge, this is the first ever trial that investigates both the effects of shock chlorination on the frequency of water-borne diseases, and the leading one to study the impact of chlorination in Sudan.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrheoal diseases,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2015
Actual trial start date
Anticipated date of last follow up 31/01/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 360
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Using a specialized software, Research Randomizer® (Urbaniak and Plous, 2013), the sample will be selected randomly from the up-to-date list of inhibitants provided by camp authority. Allocation into either arm of the study will be conducted by Research coordinator-B who will be absolutely blind of randomization done by Research Coordinator-A. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Using a specialized software, Research Randomizer® (Urbaniak and Plous, 2013), the sample will be selected randomly from the up-to-date list of inhibitants provided by camp authority. Allocation into either arm of the study will be conducted by Research coordinator-B who will be absolutely blind of randomization done by Research Coordinator-A. Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Water tanks shock chlorination 50 mg of sodium dichloroisocyanurate (NaDCC) tablets dissolved in 1 L of water Once Sample tanks will receive sodium dichloroisocyanurate (NaDCC) tablets at a concentration of 50 mg/1 L of water as recommended by WHO to achieve an endpoint of 200-500 ppm residual chlorine (WHO, 2008). Equivalent amount of distilled water will be added as placebo to control 180 Active-Treatment of Control Group
Control Group Placebo addition 50 mg of Maalus Tablets dissolved in 1 L of water. Once Equivalent amount of Maalus tablets (275mg Mg(OH)2 + 135mg Al(OH)3) will beaded to control tanks as placebo. 180 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Being registered as an inhabitant in the camp. Permanently live in the settlement during the last 3 months prior commencing trial. Restricted drinking to a single water tank. Consuming water on daily bases from that particular source. Immunocompromised patients. Malnourished patients. Individuals complaining of chronic diarrhea. Being recently on antibiotic course (¿2 wks.). 18 Year(s) 80 Year(s) Both
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 30/07/2015 National Academy of Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
Constitutional court intersection, Al-Gmhoryah Avenue, Downtown Khartoum 00 249 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to determine the impact of tanks shock chlorination on frequency of water-borne diarrheoal diseases. At start of the trial.
Secondary Outcome Measuring frequency and type of diarrhea. At the end of the trial.
Secondary Outcome Screen water for microbiological quality. At the start of the trial.
Secondary Outcome Quantify change in prevalence between both arms, if any. At both start and end of the trial.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ombada Nevachah Refugees Camp Alarda, Dar Alsalam, Omdurman Khartoum 00 249 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
M & T Research Foundation 998, Alzamalik, Taha Almahi, Gabra, Al-Klakla Avenue Khartoum 00 249 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Academy of Health Sciences Constitutional court Intersection, Al-Gmhoria Avenue, Downtown Khartoum 00 249 Sudan University
COLLABORATORS
Name Street address City Postal code Country
Academy of Health Sciences Constitutional court Intersection, Al-Gmhoria Avenue, Downtown Khartoum 00 249 Sudan
M & T Research Foundation 998, Alzamalik, Taha Almahi, Gabra, Al-Klakla Avenue Khartoum 00 249 Sudan
Ombada Nevachah Peoples' Committee Alarda, Dar Alsalam, Omdurman Khartoum 00 249 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaaddin Salih alaaddinsalih@yahoo.com 124 97 60 56 Constitutional Court intersection, Republic Avenue, Downtown Khartoum
City Postal code Country Position/Affiliation
Khartoum 00 249 Sudan Research Associate, AHS research group, National Academy of Health Sciences (AHS), Khartoum, Sudan
Role Name Email Phone Street address
Public Enquiries Musab Alfaki musabnoor946@live.com 00 147 1 333 Constitutional Court intersection, Republic Avenue, Downtown Khartoum
City Postal code Country Position/Affiliation
Khartoum 00 249 Sudan Research Associate, AHS research group, National Academy of Health Sciences (AHS), Khartoum, Sudan
Role Name Email Phone Street address
Scientific Enquiries Alaaddin Salih alaaddinsalih@yahoo.com 00 249 124 97 60 56 Constitutional Court intersection, Republic Avenue, Downtown Khartoum
City Postal code Country Position/Affiliation
Khartoum 00 249 Sudan Research Associate, AHS research group, National Academy of Health Sciences (AHS), Khartoum, Sudan
REPORTING
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