Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

Zinc Deficiency Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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]. ;

Study Design

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

Related Conditions & MeSH terms

• Zinc Deficiency

• NCT number: NCT00944723
• Study type: Interventional
• Source: University of California, Davis
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Completion date: February 2010