Water-based Zinc Efficacy Trial in Beninese Shool Children

May 9, 2014 updated by: Prof. Michael B. Zimmermann

Efficacy Study of Water as Fortification Vehicle for Zinc for Improving Zinc Status in Primary Schools Children in the Municipality of Natitingou, North of Benin.

The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
    • Atacora
      • Natitingou, Atacora, Benin
        • Kotopounga primary school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • School aged children enrolled in primary school and regularly attending class

Exclusion Criteria:

  • Severe anemia (Hb < 7 g/dl)
  • Consumption of a supplement or dietary supplement containing zinc
  • Use of drugs that affect the metabolism of zinc
  • Suffering from a chronic disease affecting the metabolism of zinc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pump water
Untreated pump water (pump water recognised as improved water source by WHO)
Placebo Comparator: Filtered water
Pump water purified by the LSF-filtering device
Device: LSF-filtering device
LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
Other Names:
  • LifeStraw Family by Vestergaard Frandsen SA
Experimental: Zinc water
Pump water purified and zinc-fortified by the LSF-filtering device
Device: LSF-filtering device
LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
Other Names:
  • LifeStraw Family by Vestergaard Frandsen SA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zinc status
Time Frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Serum zinc concentration
Baseline, midpont (varying between weeks 5-20), endpoint (week 22)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation status
Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Concentration of CRP in serum
Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Iron status
Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Haemoglobin level
Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Diarrhea incidence
Time Frame: Weekly, from baseline through to endpoint
Occurrence of diarrhea episodes monitored over 2 days weekly
Weekly, from baseline through to endpoint
Malaria prevalence
Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Screening of HRP-II antigen
Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
ALRI prevalence
Time Frame: At baseline and endpoint
Auscultation and respiratory frequence (no. of chest movements per minute)
At baseline and endpoint
Anthropometric indices
Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Measurement of height, weight and mid-upper arm circumference for the assessment of height-for-age, weight-for-age and BMI-for-age Z-scores.
Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Michael B. Zimmermann

Collaborators

Université d'Abomey-Calavi

Investigators

  • Study Chair: Michael B Zimmermann, Prof. Dr.med, ETH Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • LSF_Zn_school

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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