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Clinical Trials/NCT00944723
NCT00944723CompletedPhase 4

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

University of California, Davis1 site in 1 country132 target enrollmentStarted: August 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
Plasma zinc concentration

Study Overview

Brief 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].

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • apparently healthy males

Exclusion Criteria

  • Hemoglobin <80 g/L

Outcomes

Primary Outcomes

Plasma zinc concentration

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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