NCT00944723

Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.

Detailed description

The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed: 1. Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology. 2. A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals \[negative control group\]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals \[positive control group\].

Conditions

• Zinc Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc-fortified bread	Bread made with zinc-fortified wheat flour
DIETARY_SUPPLEMENT	Zinc supplement	Liquid supplement with zinc
DIETARY_SUPPLEMENT	Non-fortified bread	Daily consumption of non-fortified bread
DIETARY_SUPPLEMENT	Placebo supplement	Daily intake of placebo supplement

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2009-07-23
• Last updated: 2010-02-19

Locations

1 site across 1 country: Senegal