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Dehydration Among School Children- Mali

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ClinicalTrials.gov Identifier: NCT01768234
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : October 1, 2013
Sponsor:
Collaborator:
Save the Children
Information provided by (Responsible Party):
Matthew Freeman, MPH, PhD, Emory University

Brief Summary:

There is a large body of evidence from adult populations suggesting cognition in adults is affected by hydration status. The few studies conducted in the global North in populations of schoolchildren indicate that drinking water has an impact on pupil performance on basic cognitive tasks. No studies assessing the impact of dehydration and cognition in schoolchildren have been carried out in the global South, where access to water is the poorest and dehydration prevalence is likely higher. This study will examine the effect of drinking supplementary water during the school day on hydration status and on cognitive test scores in schoolchildren in Mali, West Africa.

The investigators hypothesize that providing supplemental water will result in a decrease in prevalence of dehydration in the study group and will result in an improved performance on cognitive test scores.

Data will be collected from up to four purposively-selected schools in the Sikasso region of Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be eligible for recruitment. Research staff will explain the study to pupils at the school and individually request informed oral assent for participation. A waiver of parental consent for pupil interviews will be secured from the Ministry of Education. At each school, school directors will be asked to sign in loco parentis ("in the place of parent") on behalf of the pupil participants.

Children that assent to participate in the study will be randomly allocated to the intervention or control group. Data collection will take place at each school over two days within a one-week period, with one study group tested on each of the two days. On the intervention testing day, all study participants will receive supplementary water. On the control testing day, no study participants will receive supplementary water. Testing procedures in both groups is identical and will include a five-minute interview, two cognitive testing sessions of 45 minutes each, and collection of two urine samples during the day. None of these activities collect personal data or identifiers, and the urine sample will not be stored.

All data collection will occur at the school and will be conducted by trained local enumerators. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.


Condition or disease Intervention/treatment
Dehydration Other: Supplemental water

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognitive Effects of Drinking Water and Improving Hydration Status Among Schoolchildren
Study Start Date : January 2013
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Supplemental water
This arm receives up to 2 L of supplemental water during the course of the testing day.
Other: Supplemental water
1-2L of supplemental water provided between pre-test and post-test
No Intervention: Control
No supplemental water provided



Primary Outcome Measures :
  1. Cognitive test performance [ Time Frame: 5-8 hours following intervention ]
    Measured by paper-based tests of visual attention, visual memory, short-term member, and visuomotor skills


Secondary Outcome Measures :
  1. Perceived difficulty of task [ Time Frame: 5-8 hours followign intervention ]
    Measured by self-report

  2. Hydration status [ Time Frame: 5-8 hours following intervention ]
    Measured by urine specific gravity,urine color, and self-reported thirst



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Attend a school pre-selected for the study
  • Attend grade level 3-6
  • Understand and respond to verbal instruction

Exclusion Criteria:

  • Unable to write down a string of numbers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768234


Locations
Mali
Sikasso rural
Sikasso, Mali
Sponsors and Collaborators
Emory University
Save the Children
Investigators
Principal Investigator: Matthew Freeman, PhD MPH Emory University

Responsible Party: Matthew Freeman, MPH, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01768234     History of Changes
Other Study ID Numbers: IRB00062354
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Matthew Freeman, MPH, PhD, Emory University:
cognition
hydration
schoolchildren

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes