NCT01790321

Water-based Zinc Efficacy Trial in Beninese Shool Children

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Prof. Michael B. Zimmermann · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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

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

• Zinc Deficiency

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-02-13
• Last updated: 2014-05-12

Locations

1 site across 1 country: Benin