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Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya

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ClinicalTrials.gov Identifier: NCT02162238
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 3, 2014
Sponsor:
Collaborators:
ETH Zurich
Maseno University
Information provided by (Responsible Party):
Wageningen University

Tracking Information
First Submitted Date  ICMJE April 16, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
number of participants with adequate zinc intake above the EAR (estimated average requirement) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • number of participants with increased serum zinc level from baseline [ Time Frame: at 3 months into intervention and at 6 months ]
  • morbidity incidence [ Time Frame: every week up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya
Official Title  ICMJE Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya
Brief Summary

Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is 73.5% and this is likely due at least in part to low bioavailable zinc from the local cereal-based diet. Interventions that will increase zinc intake could prove useful in the effort to control zinc deficiency. A potential strategy is to increase zinc intake through enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A, Switzerland) is capable of purifying water and at the same time enriching it with zinc at a variable concentration with mean delivery of approximately 1-4mg/L.

Aims of the study: The primary aim of this study will be to quantify in under 5 year old children the contribution of the household LSF device to zinc intake and dietary zinc bioavailability in participating households. Secondary objectives are; 1) to assess change in serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to characterize composition of the intestinal flora of children in the intervention group compared to control.

Study Design and Methods:

Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc delivery system.

Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2 non-consecutive days in the dry and wet season. Selected food samples will be collected for direct analysis of zinc and phytic acid content, to supplement data from food composition tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc intakes in this age group and the EAR cut-off method will be used to estimate the proportion at risk of inadequate intakes.

Data on water intake from the LSF device will be obtained by personal diaries and tally counters. The Zn concentration of the filtered water will be measured weekly. Using these data and the data from the dietary assessment, the contribution of the LSF zinc delivery to the overall dietary zinc intake will be estimated.

The effectiveness study will be conducted as a 6-month double blind randomised trial with 3 assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be collected from under 5 year old children enrolled in the households for determination of serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in the intervention and control group to assess the composition of the gut microflora and gut inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and endpoint of the study. Weekly active surveillance for incidence and severity of malaria, diarrhea and other infectious diseases will be done by questionnaire.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Zinc Deficiency
Intervention  ICMJE Device: 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 Nephelometric Turbidity units turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc enrichment 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
Study Arms  ICMJE
  • Placebo Comparator: purified water
    Filtered water Pump water purified by the LSF-filtering device Intervention: Device: LSF-filtering device
  • Experimental: zinc enriched purified water
    Zinc water water purified and zinc-enriched by the LSF-filtering device Intervention: Device: LSF-filtering device
    Intervention: Device: LSF-filtering device
Publications * Kujinga P, Galetti V, Onyango E, Jakab V, Buerkli S, Andang'o P, Brouwer ID, Zimmermann MB, Moretti D. Effectiveness of zinc-fortified water on zinc intake, status and morbidity in Kenyan pre-school children: a randomised controlled trial. Public Health Nutr. 2018 Oct;21(15):2855-2865. doi: 10.1017/S1368980018001441. Epub 2018 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2014)
186
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children (under 5 year olds) in consenting households will participate in the study

Exclusion Criteria:

  • Subjects with severe anemia (Hb<7g/dl)
  • Subjects receiving zinc supplementation
  • Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
  • Subjects participating in any other clinical trials in the study site
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162238
Other Study ID Numbers  ICMJE Kisumu dietary Zn Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE
  • ETH Zurich
  • Maseno University
Investigators  ICMJE
Principal Investigator: Diego Moretti, PhD ETH Zurich
Study Director: Inge D Brouwer, PhD Wageningen University
Study Chair: Michael B Zimmerman, PhD ETH Zurich and Wageningen University
Study Director: Pauline Andango, PhD Maseno University
PRS Account Wageningen University
Verification Date September 2014

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