Water-based Zinc Efficacy Trial in Beninese Shool Children

Zinc Deficiency Clinical Trial

Official title:

Efficacy Study of Water as Fortification Vehicle for Zinc for Improving Zinc Status in Primary Schools Children in the Municipality of Natitingou, North of Benin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790321
• Other study ID #: LSF_Zn_school
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: May 9, 2014
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Benin: Comité National d'Ethique pour la Recherche en Santé
• Study type: Interventional

Clinical Trial 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.

Description:

A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Device:
• LSF-filtering device
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%.

Locations

Country	Name	City	State
Benin	Kotopounga primary school	Natitingou	Atacora

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Michael B. Zimmermann	Université d'Abomey-Calavi

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zinc status	Serum zinc concentration	Baseline, midpont (varying between weeks 5-20), endpoint (week 22)	No
Secondary	Inflammation status	Concentration of CRP in serum	Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)	No
Secondary	Iron status	Haemoglobin level	Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)	No
Secondary	Diarrhea incidence	Occurrence of diarrhea episodes monitored over 2 days weekly	Weekly, from baseline through to endpoint	No
Secondary	Malaria prevalence	Screening of HRP-II antigen	Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)	No
Secondary	ALRI prevalence	Auscultation and respiratory frequence (no. of chest movements per minute)	At baseline and endpoint	No
Secondary	Anthropometric indices	Measurement of height, weight and mid-upper arm circumference for the assessment of height-for-age, weight-for-age and BMI-for-age Z-scores.	Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)	No