NCT01790321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

February 7, 2013

Last Update Submit

May 9, 2014

Conditions

Zinc Deficiency

Outcome Measures

Primary Outcomes (1)

  • Zinc status

    Serum zinc concentration

    Baseline, midpont (varying between weeks 5-20), endpoint (week 22)

Secondary Outcomes (6)

  • Inflammation status

    Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

  • Iron status

    Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

  • Diarrhea incidence

    Weekly, from baseline through to endpoint

  • Malaria prevalence

    Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)

  • ALRI prevalence

    At baseline and endpoint

  • +1 more secondary outcomes

Study Arms (3)

Pump water

NO INTERVENTION

Untreated pump water (pump water recognised as improved water source by WHO)

Filtered water

PLACEBO COMPARATOR

Pump water purified by the LSF-filtering device

Device: LSF-filtering device

Zinc water

EXPERIMENTAL

Pump water purified and zinc-fortified by the LSF-filtering device

Device: LSF-filtering device

Interventions

LSF-filtering deviceDEVICE

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
Filtered waterZinc water

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School aged children enrolled in primary school and regularly attending class

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kotopounga primary school

Natitingou, Atakora Department, Benin

Location

Related Publications (2)

  • 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: 26609168DERIVED

  • Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.

    PMID: 26468121DERIVED

Study Officials

  • Michael B Zimmermann, Prof. Dr.med

    ETH Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.med

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 13, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

BE(1)