Water-based Zinc Efficacy Trial in Beninese Shool Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pump water

Untreated pump water (pump water recognised as improved water source by WHO)

Group Type NO_INTERVENTION

No interventions assigned to this group

Filtered water

Pump water purified by the LSF-filtering device

Group Type PLACEBO_COMPARATOR

LSF-filtering device

Intervention Type 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%.

Zinc water

Pump water purified and zinc-fortified by the LSF-filtering device

Group Type EXPERIMENTAL

LSF-filtering device

Intervention Type 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%.

Interventions

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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%.

Intervention Type DEVICE

Other Intervention Names

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LifeStraw Family by Vestergaard Frandsen SA

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes