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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
  Purpose

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.


Condition Intervention Phase
Zinc Deficiency
Diarrhea
Device: zinc enriching filter (LifeStrawFamily)
Device: placebo filter
Other: disinfection tablets
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 317
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention filter
children consuming purified and zinc enriched water delivered by a household-based water filter
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)
Placebo Comparator: placebo filter
children consuming purified water delivered by a household-based water filter
Device: placebo filter
filter purifies water
Other Name: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
Active Comparator: disinfection tablets
children will consume water treated with government promoted disinfection tablets (aquatabs)
Other: disinfection tablets
government promoted tablets disinfect water
Other Name: Aquatabs water purification tablets

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472211

Locations
Benin
Hopital de Zone
Natitingou, Atacora, Benin
Sponsors and Collaborators
Swiss Federal Institute of Technology
Université d'Abomey-Calavi
Investigators
Study Chair: Michael Zimmermann, Prof. Dr.med. Swiss Federal Institute of Technology
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01472211     History of Changes
Other Study ID Numbers: LSF_zinc_study
Study First Received: November 9, 2011
Last Updated: June 17, 2013
Health Authority: Benin: Comité National Provisoire d'Ethique pour la Recherche en Santé

Additional relevant MeSH terms:
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014