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Water-based Zinc Intervention Trial in Zinc Deficient Children

This study has been terminated.
(Zn released from vehicle led to fortification levels higher than planned. New filter will be developed.)
Sponsor:
Collaborator:
Université d'Abomey-Calavi
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01472211
First received: November 9, 2011
Last updated: June 17, 2013
Last verified: June 2013

November 9, 2011
June 17, 2013
September 2011
December 2011   (final data collection date for primary outcome measure)
Zinc status [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
At baseline, endpoint and at a randomly assigned screening between month 1 and 11, a 6 ml whole blood sample will be collected by venipuncture in 2-5y children (N=270). The blood sample will be used to determine concentration of zinc in the serum (SZn). Inflammation indicator C-reactive protein (CRP) will be analysed to adjust SZn values.
Same as current
Complete list of historical versions of study NCT01472211 on ClinicalTrials.gov Archive Site
  • Gut microbiota characterisation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    At baseline and month 2, stool samples will be collected in 60 children (20 per study arm) for gut flora characterisation.
  • Iron status [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    At baseline, endpoint and at a randomly assigned screening between month 1 and 11, a 6 ml whole blood sample will be collected by venipuncture in 2-5y children (N=270). The blood sample will be used to determine the levels of haemoglobin (Hb) and serum ferritin (SF) for the assessment of iron status.
  • Growth rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At baseline, midpoint and endpoint weight, height and MUAC will be measured in 2-5y children (N=270). Anthropometric measurements will be used to determine growth rate.
  • Diarrhea prevalence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Study children will be weekly surveyed for diarrhea occurrence. Mothers/tutors will be requested to report any diarrhea episode occurred in the last 48 hours.
Same as current
Not Provided
Not Provided
 
Water-based Zinc Intervention Trial in Zinc Deficient Children
An Efficacy Trial of a Gravity-fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Preschool Children and Pregnant Women From Rural Settings With Poor Access to Potable Water in Benin.

The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water.

To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population.

The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Zinc Deficiency
  • Diarrhea
  • Device: zinc enriching filter (LifeStrawFamily)
    filter purifies water and enriches it with zinc at 1-4 mg/l.
    Other Name: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
  • Device: placebo filter
    filter purifies water
    Other Name: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
  • Other: disinfection tablets
    government promoted tablets disinfect water
    Other Name: Aquatabs water purification tablets
  • Experimental: intervention filter
    children consuming purified and zinc enriched water delivered by a household-based water filter
    Intervention: Device: zinc enriching filter (LifeStrawFamily)
  • Placebo Comparator: placebo filter
    children consuming purified water delivered by a household-based water filter
    Intervention: Device: placebo filter
  • Active Comparator: disinfection tablets
    children will consume water treated with government promoted disinfection tablets (aquatabs)
    Intervention: Other: disinfection tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
317
September 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2-5 year old children
  • subjects residing in the study area for the whole study period

Exclusion Criteria:

  • subject with severe anemia (Hb < 7 g/dl)
  • subjects affected by chronic medical illnesses known to interact with zinc metabolism
  • subjects receiving zinc supplementation or other medicines that may affect zinc metabolism
Both
2 Years to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Benin
 
NCT01472211
LSF_zinc_study
Yes
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Université d'Abomey-Calavi
Study Chair: Michael Zimmermann, Prof. Dr.med. Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP