Water-based Zinc Efficacy Trial in Beninese Shool Children

Study Overview
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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.

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.

Official Title
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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.

Conditions
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Zinc Deficiency

Intervention / Treatment
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* Device: LSF-filtering device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pump water<br>Untreated pump water (pump water recognised as improved water source by WHO) | |
| Placebo Comparator: Filtered water<br>Pump water purified by the LSF-filtering device | Device: LSF-filtering device<br>* 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%.<br>* Other names: LifeStraw Family by Vestergaard Frandsen SA;|
| Experimental: Zinc water<br>Pump water purified and zinc-fortified by the LSF-filtering device | Device: LSF-filtering device<br>* 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%.<br>* Other names: LifeStraw Family by Vestergaard Frandsen SA;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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