Water-based Zinc Efficacy Trial in Beninese Shool Children

P

Prof. Michael B. Zimmermann

Status

Completed

Conditions

Zinc Deficiency

Treatments

Device: LSF-filtering device

Study type

Interventional

Funder types

Other

Identifiers

NCT01790321
LSF_Zn_school

Details and patient eligibility

About

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.

Full 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.

Enrollment

278 patients

Sex

All

Ages

6 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

278 participants in 3 patient groups, including a placebo group

Pump water
No Intervention group
Description:
Untreated pump water (pump water recognised as improved water source by WHO)
Filtered water
Placebo Comparator group
Description:
Pump water purified by the LSF-filtering device
Treatment:
Device: LSF-filtering device
Zinc water
Experimental group
Description:
Pump water purified and zinc-fortified by the LSF-filtering device
Treatment:
Device: LSF-filtering device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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