Hypertension Clinical Trial
Official title:
Health Impacts of a Climate Change Adaptation Strategy to Address Drinking-water Salinity in Coastal Bangladesh
NCT number | NCT02746003 |
Other study ID # | PR-15096 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | May 2019 |
Background (brief):
1. Burden:
Excessive salinity is common in groundwater aquifers across south-western coastal
Bangladesh. Higher adult mean systolic and diastolic blood pressure and increased risk
of gestational hypertension has been observed among those who drank tube-well water with
high sodium content.
2. Knowledge gap:
Managed Aquifer Recharge (MAR) systems, that inject freshwater into shallow aquifers,
reduce drinking water salinity, have been successfully installed in the south-western
area, providing year-round freshwater. However, the health benefits and risks of MAR
water have not been measured.
3. Relevance:
If drinking MAR water can reduce hypertension in adults and pregnant women, while showing
minimal risk of microbiological and chemical contamination, scale up can be considered.
Hypothesis (if any):
Mean systolic and diastolic blood pressure will be lower among the adult population who drink
MAR water compared to people drinking saline or brackish groundwater Objectives: To determine
1. If providing access to MAR water for drinking and food preparation reduces blood
pressure among the adult population > 20 years of age.
2. If providing access to MAR water for drinking and food preparation during pregnancy can
reduce blood pressure among pregnant women.
3. If MAR water is contaminated with E coli and fecal coliforms.
4. Whether the MAR water is contaminated with dissolved constituents mobilized from aquifer
sediments that are known to be harmful to human health.
Methods:
A stepped-wedge RCT will be conducted among communities before and after the intervention
roll out. Study investigators will collect baseline information from all sites in the first
monthly block (step) when no one will drink MAR water. There will be promoters who will
convey messages regarding exclusive use of MAR water for drinking and cooking, at home and
elsewhere. Measurements will be made by trained research assistants once every month. MAR
water, pond water, groundwater and household stored water samples will be collected and
tested once every month.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | May 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Participants >20 years (both male and female) - Pregnant women Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dr. Md. Mahbubur Rahman | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Emory University, University College, London, University of Dhaka |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction of mean systolic blood pressure among the >20 populations | 5 months |
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