Water-based Zinc Intervention Trial in Zinc Deficient Children

NCT01472211 | Terminated Early Phase 1 DMC

• 1 other identifier: LSF_zinc_study
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zinc Deficiency; Diarrhea

Outcome Measures

Primary Outcomes (1)

• Zinc status

  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.

  12 months

Secondary Outcomes (4)

• Gut microbiota characterisation

  2 months

• Iron status

  12 months

• Growth rate

  12 months

• Diarrhea prevalence

  12 months

Study Arms (3)

intervention filter

EXPERIMENTAL

children consuming purified and zinc enriched water delivered by a household-based water filter

Device: zinc enriching filter (LifeStrawFamily)

placebo filter

PLACEBO COMPARATOR

children consuming purified water delivered by a household-based water filter

Device: placebo filter

disinfection tablets

ACTIVE COMPARATOR

children will consume water treated with government promoted disinfection tablets (aquatabs)

Other: disinfection tablets

Interventions

zinc enriching filter (LifeStrawFamily) DEVICE

filter purifies water and enriches it with zinc at 1-4 mg/l.

Also known as: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)

intervention filter

placebo filter DEVICE

filter purifies water

Also known as: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)

placebo filter

disinfection tablets OTHER

government promoted tablets disinfect water

Also known as: Aquatabs water purification tablets

disinfection tablets

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Université d'Abomey-Calavi: collaborator

Study Sites (1)

Hopital de Zone

Natitingou, Atakora Department, Benin

Location

Related Publications (1)

• Galetti V, Mitchikpe CE, Kujinga P, Tossou F, Hounhouigan DJ, Zimmermann MB, Moretti D. Rural Beninese Children Are at Risk of Zinc Deficiency According to Stunting Prevalence and Plasma Zinc Concentration but Not Dietary Zinc Intakes. J Nutr. 2016 Jan;146(1):114-23. doi: 10.3945/jn.115.216606. Epub 2015 Nov 25.

  PMID: 26609168 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Disinfection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sterilization; Infection Control; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Michael Zimmermann, Prof. Dr.med.

  Swiss Federal Institute of Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

BE (1)