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Completed

NCT Number: NCT02162238

Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya

Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is 73.5% and this is likely due at least in part to low bioavailable zinc from the local cereal-based diet. Interventions that will increase zinc intake could prove useful in the effort to control zinc deficiency. A potential strategy is to increase zinc intake through enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A, Switzerland) is capable of purifying water and at the same time enriching it with zinc at a variable concentration with mean delivery of approximately 1-4mg/L.

Aims of the study: The primary aim of this study will be to quantify in under 5 year old children the contribution of the household LSF device to zinc intake and dietary zinc bioavailability in participating households. Secondary objectives are; 1) to assess change in serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to characterize composition of the intestinal flora of children in the intervention group compared to control.

Study Design and Methods:

Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc delivery system.

Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2 non-consecutive days in the dry and wet season. Selected food samples will be collected for direct analysis of zinc and phytic acid content, to supplement data from food composition tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc intakes in this age group and the EAR cut-off method will be used to estimate the proportion at risk of inadequate intakes.

Data on water intake from the LSF device will be obtained by personal diaries and tally counters. The Zn concentration of the filtered water will be measured weekly. Using these data and the data from the dietary assessment, the contribution of the LSF zinc delivery to the overall dietary zinc intake will be estimated.

The effectiveness study will be conducted as a 6-month double blind randomised trial with 3 assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be collected from under 5 year old children enrolled in the households for determination of serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in the intervention and control group to assess the composition of the gut microflora and gut inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and endpoint of the study. Weekly active surveillance for incidence and severity of malaria, diarrhea and other infectious diseases will be done by questionnaire.

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Key information

Conditions

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maseno University

Kisumu, Nyanza, Kenya

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children (under 5 year olds) in consenting households will participate in the study

Exclusion criteria

  • Subjects with severe anemia (Hb<7g/dl)
  • Subjects receiving zinc supplementation
  • Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
  • Subjects participating in any other clinical trials in the study site

Treatment and study plan

LSF-filtering device

Device

Device: LSF-filtering device LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 Nephelometric Turbidity units turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc enrichment 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. number of participants with adequate zinc intake above the EAR (estimated average requirement)

    Time frame: 6 months

Secondary outcomes

  1. number of participants with increased serum zinc level from baseline

    Time frame: at 3 months into intervention and at 6 months

  2. morbidity incidence

    Time frame: every week up to 24 weeks

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • ETH Zurich
  • Maseno University

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2014
Registry last updated
Sep 3, 2014

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

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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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