Clinical trial NCT01790321: Water-based Zinc Efficacy Trial in Beninese Shool Children
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Université d'Abomey-Calavi
First posted: 2013-02-13
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zinc status
timeFrame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Secondary outcomes:
measure: Inflammation status
timeFrame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
measure: Iron status
timeFrame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
measure: Diarrhea incidence
timeFrame: Weekly, from baseline through to endpoint
measure: Malaria prevalence
timeFrame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
measure: ALRI prevalence
timeFrame: At baseline and endpoint
measure: Anthropometric indices
timeFrame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Other outcomes:
Locations:
city: Natitingou
country: Benin
facility: Kotopounga primary school
state: Atacora
Study officials:
affiliation: ETH Zurich
name: Michael B Zimmermann, Prof. Dr.med
role: STUDY_CHAIR
References:
citation: Galetti V, Mitchikpe CE, Kujinga P, Tossou F, Hounhouigan DJ, Zimmermann MB, Moretti D. Rural Beninese Children Are at Risk of Zinc Deficiency According to Stunting Prevalence and Plasma Zinc Concentration but Not Dietary Zinc Intakes. J Nutr. 2016 Jan;146(1):114-23. doi: 10.3945/jn.115.216606. Epub 2015 Nov 25.
citation: Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.