An interventional study of LSF-filtering device in Zinc Deficiency, sponsored by Prof. Michael B. Zimmermann. Completed at 1 site in Benin. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by Prof. Michael B. Zimmermann · Not applicable and Interventional
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.
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.
Prof. Michael B. Zimmermann is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Untreated pump water (pump water recognised as improved water source by WHO)
Pump water purified by the LSF-filtering device
Device: LSF-filtering device
Pump water purified and zinc-fortified by the LSF-filtering device
Device: LSF-filtering 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%.
Also known as: LifeStraw Family by Vestergaard Frandsen SA
Zinc status
Serum zinc concentration
Time frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Inflammation status
Concentration of CRP in serum
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Iron status
Haemoglobin level
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Diarrhea incidence
Occurrence of diarrhea episodes monitored over 2 days weekly
Time frame: Weekly, from baseline through to endpoint
Malaria prevalence
Screening of HRP-II antigen
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
ALRI prevalence
Auscultation and respiratory frequence (no. of chest movements per minute)
Time frame: At baseline and endpoint
Anthropometric indices
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.
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Prof. Michael B. Zimmermann