NCT02746003

Brief Summary

Background (brief):

  1. 1.Burden:
  2. 2.Knowledge gap:
  3. 3.Relevance:
  4. 4.If providing access to MAR water for drinking and food preparation reduces blood pressure among the adult population \> 20 years of age.
  5. 5.If providing access to MAR water for drinking and food preparation during pregnancy can reduce blood pressure among pregnant women.
  6. 6.If MAR water is contaminated with E coli and fecal coliforms.
  7. 7.Whether the MAR water is contaminated with dissolved constituents mobilized from aquifer sediments that are known to be harmful to human health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 29, 2018

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

April 3, 2016

Last Update Submit

June 28, 2018

Conditions

Keywords

drinking watersalinity

Outcome Measures

Primary Outcomes (1)

  • reduction of mean systolic blood pressure among the >20 populations

    5 months

Study Arms (2)

Managed Aquifer Recharge water

OTHER

All the study population will receive the intervention by a random allocation over the study period. The study participants will be in both intervention and control at different times.

Other: Managed Aquifer Recharge water

Control

OTHER

All the study population will receive the intervention by a random allocation over the study period. The study participants will be in both intervention and control arms at different times.

Other: Managed Aquifer Recharge water

Interventions

Rain water will be recharged through slow sand filter and recharge wells into the confined underground aquifer and the surrounding community will abstract the water for drinking and cooking purposes

ControlManaged Aquifer Recharge water

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants \>20 years (both male and female)
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Md. Mahbubur Rahman

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

  • Naser AM, Unicomb L, Doza S, Ahmed KM, Rahman M, Uddin MN, Quraishi SB, Selim S, Shamsudduha M, Burgess W, Chang HH, Gribble MO, Clasen TF, Luby SP. Stepped-wedge cluster-randomised controlled trial to assess the cardiovascular health effects of a managed aquifer recharge initiative to reduce drinking water salinity in southwest coastal Bangladesh: study design and rationale. BMJ Open. 2017 Sep 1;7(9):e015205. doi: 10.1136/bmjopen-2016-015205.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Md. Mahbubur Rahman

    International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Mahbubur Rahman

CONTACT

Md. Salam Khan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

June 29, 2018

Record last verified: 2017-09

Locations