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Completed

NCT Number: NCT01790321

Water-based Zinc Efficacy Trial in Beninese Shool Children

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.

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Key information

Conditions

Zinc Deficiency

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kotopounga primary school

Natitingou, Atakora Department, Benin

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LSF-filtering device

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%.

Other names: LifeStraw Family by Vestergaard Frandsen SA

Primary outcomes

  1. Zinc status

    Time frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)

    Serum zinc concentration

Secondary outcomes

  1. Inflammation status

    Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

    Concentration of CRP in serum

  2. Iron status

    Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

    Haemoglobin level

  3. Diarrhea incidence

    Time frame: Weekly, from baseline through to endpoint

    Occurrence of diarrhea episodes monitored over 2 days weekly

  4. Malaria prevalence

    Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

    Screening of HRP-II antigen

  5. ALRI prevalence

    Time frame: At baseline and endpoint

    Auscultation and respiratory frequence (no. of chest movements per minute)

  6. Anthropometric indices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prof. Michael B. Zimmermann

Other

Collaborators

  • Université d'Abomey-Calavi

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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