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Water-based Zinc Efficacy Trial in Beninese Shool Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01790321
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : May 12, 2014
Sponsor:
Collaborator:
Université d'Abomey-Calavi
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Zinc Deficiency Device: LSF-filtering device Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Pump water
Untreated pump water (pump water recognised as improved water source by WHO)
Placebo Comparator: Filtered water
Pump water purified 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%.
Other Name: LifeStraw Family by Vestergaard Frandsen SA
Experimental: Zinc water
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%.
Other Name: LifeStraw Family by Vestergaard Frandsen SA


Outcome Measures
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Primary Outcome Measures :
  1. Zinc status [ Time Frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22) ]
    Serum zinc concentration


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790321


Locations
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Benin
Kotopounga primary school
Natitingou, Atacora, Benin
Sponsors and Collaborators
Prof. Michael B. Zimmermann
Université d'Abomey-Calavi
Investigators
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Study Chair: Michael B Zimmermann, Prof. Dr.med ETH Zurich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr.med, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01790321    
Other Study ID Numbers: LSF_Zn_school
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014