Water-based Zinc Efficacy Trial in Beninese Shool Children

Not Applicable

Completed

• Conditions: Zinc Deficiency
• Interventions: Device: LSF-filtering device

• Registration Number: NCT01790321
• Lead Sponsor: Prof. Michael B. Zimmermann

Brief 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filtered water	LSF-filtering device	Pump water purified by the LSF-filtering device
Zinc water	LSF-filtering device	Pump water purified and zinc-fortified by the LSF-filtering device

Primary Outcome Measures

Name	Time	Method
Zinc status	Baseline, midpont (varying between weeks 5-20), endpoint (week 22)	Serum zinc concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kotopounga primary school; 🇧🇯 Natitingou, Atacora, Benin