Clinical Trials Logo

Clinical Trial Summary

SODISWATER was a health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was carried out by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea or dysentery.

Caregivers for the participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries.

TESTABLE RESEARCH HYPOTHESES:

Health Impact Assessment: Children who use solar disinfected water will have:

(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance


Clinical Trial Description

The current evidence base for solar disinfection in the prevention of diarrhoeal disease in children rests on three published studies. All share two significant weaknesses: all were carried out in Kenya, in communities which have very high incidences of diarrhoeal disease and water characterised by high levels of both turbidity and microbial contamination. Furthermore, neither of the studies of diarrhoeal disease distinguished between dysentery (associated with significant risk of mortality) and other sorts of diarrhoea, which carry a far lower risk. The present study will extend the evidence base into communities at lower risk and with higher water quality. Furthermore, by using pictorial diaries, dysentery can be analysed as a specific health endpoint. Diarrhoea will be recorded consistent with the World Health organisation definition: three or more loose or watery stools in a 24-hour period and/or stools containing blood or mucus.

AIM OF THE PROJECT IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:

The primary aim of the SODISWATER PROJECT is to demonstrate that SODIS is an appropriate intervention against diarrhoeal and waterborne disease among communities in developing countries and those affected by natural or man-made disasters by conducting multi-centred epidemiologically controlled Health Impact Assessments of the SODIS technique across the African Continent under a variety of social, geographical and climactic conditions.

SCIENTIFIC OBJECTIVES OF SODISWATER IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:

1. Assessment of the change in health reasonably attributed to the provision of solar disinfected drinking water at the point of use in 3 countries (Kenya, Zimbabwe and Cambodia).

2. Assessment of the relationship between solar disinfected drinking water and selected health indicators (including morbidity due to non-bloody diarrhoea and dysentery, weight loss, mortality, growth rates, productivity, care-giver burden, and school attendance. Mortality will also be monitored but the sample sizes are of insufficient size to produce detailed information and scaling up, to account for this is not possible due to prohibitive costs).

3. Demonstration of the effectiveness of SODIS at household level. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01306383
Study type Interventional
Source Royal College of Surgeons, Ireland
Contact
Status Completed
Phase N/A
Start date June 2008
Completion date May 2010

See also
  Status Clinical Trial Phase
Completed NCT01214785 - Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India N/A
Recruiting NCT05073003 - A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants Phase 1/Phase 2
Completed NCT01969214 - Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea N/A
Completed NCT01202383 - Double-blinded Trial of Household-based Chlorination in India Phase 3
Completed NCT00979056 - Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin Phase 3
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Completed NCT02072629 - HCU: Can VHVs Trained in ICCM Improve Care for Children N/A
Completed NCT00408356 - Immunological and Clinical Responses to Zinc in Children With Diarrhoea Phase 3
Completed NCT01517230 - Can Mass Media Campaigns Reduce Child Mortality N/A
Completed NCT02858609 - Improving the Diagnosis of Diarrhoea in Emergency Rooms N/A
Completed NCT00352716 - Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children Phase 3
Active, not recruiting NCT02606526 - Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda Phase 3
Completed NCT00352989 - Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children Phase 3
Completed NCT00324285 - Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children. Phase 3
Recruiting NCT02144168 - The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients N/A
Withdrawn NCT01491659 - A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate Phase 4
Completed NCT02797353 - Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan N/A
Completed NCT01557673 - Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow Phase 1/Phase 2
Completed NCT00823056 - The Effect of Probiotics on Infections in Toddlers Phase 3
Completed NCT01154803 - Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection N/A