Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

Phase 4

Completed

• Conditions: Zinc Deficiency
• Interventions: Dietary Supplement: Zinc-fortified bread; Dietary Supplement: Zinc supplement; Dietary Supplement: Placebo supplement; Dietary Supplement: Non-fortified bread

• Registration Number: NCT00944723
• Lead Sponsor: University of California, Davis

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 Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2009-08
• Primary Completion: 2010-01
• Status Verified: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 132

Inclusion Criteria

• apparently healthy males

Exclusion Criteria

• Hemoglobin <80 g/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc-fortified bread (10 mg zinc/d)	Zinc-fortified bread	Daily consumption of zinc fortified bread for 1 month
Zinc-fortified bread (10 mg zinc/d)	Placebo supplement	Daily consumption of zinc fortified bread for 1 month
Zinc fortified bread (20 mg zinc/d)	Zinc-fortified bread	Daily consumption of zinc fortified bread for 1 month.
Zinc fortified bread (20 mg zinc/d)	Placebo supplement	Daily consumption of zinc fortified bread for 1 month.
Zinc supplemented group	Zinc supplement	Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)
Zinc supplemented group	Non-fortified bread	Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)
Non-fortified group	Placebo supplement	Daily consumption of non-fortified bread and a placebo supplement for 1 month.
Non-fortified group	Non-fortified bread	Daily consumption of non-fortified bread and a placebo supplement for 1 month.

Primary Outcome Measures

Name	Time	Method
Plasma zinc concentration	1 month

Trial Locations

Locations (1)

Helen Keller International; 🇸🇳 Dakar, Senegal