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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162238
• Other study ID #: Kisumu dietary Zn Study
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: September 2, 2014
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switserland: Federal Institute of TechnologyNetherlands: Wageningen University and research centreKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

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%.

Locations

Country	Name	City	State
Kenya	Maseno University	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Maseno University, University of Zurich

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with adequate zinc intake above the EAR (estimated average requirement)		6 months	No
Secondary	number of participants with increased serum zinc level from baseline		at 3 months into intervention and at 6 months	No
Secondary	morbidity incidence		every week up to 24 weeks	No