Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

Study Overview
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Brief Summary
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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
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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: Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology. 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].

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

Conditions
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Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: Zinc-fortified bread
* Dietary Supplement: Zinc supplement
* Dietary Supplement: Non-fortified bread
* Dietary Supplement: Placebo supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: apparently healthy males Exclusion Criteria: Hemoglobin <80 g/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc-fortified bread (10 mg zinc/d)<br>Daily consumption of zinc fortified bread for 1 month | Dietary Supplement: Zinc-fortified bread<br>* Bread made with zinc-fortified wheat flour<br>* Other names: Les Grands Moulins de Dakar;Dietary Supplement: Placebo supplement<br>* Daily intake of placebo supplement<br>* Other names: B-vitamins, DSM;|
| Experimental: Zinc fortified bread (20 mg zinc/d)<br>Daily consumption of zinc fortified bread for 1 month. | Dietary Supplement: Zinc-fortified bread<br>* Bread made with zinc-fortified wheat flour<br>* Other names: Les Grands Moulins de Dakar;Dietary Supplement: Placebo supplement<br>* Daily intake of placebo supplement<br>* Other names: B-vitamins, DSM;|
| Experimental: Zinc supplemented group<br>Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d) | Dietary Supplement: Zinc supplement<br>* Liquid supplement with zinc<br>* Other names: Zinc sulfate and B vitamins, DSM;Dietary Supplement: Non-fortified bread<br>* Daily consumption of non-fortified bread<br>* Other names: Les Grands Moulins de Dakar;|
| Placebo Comparator: Non-fortified group<br>Daily consumption of non-fortified bread and a placebo supplement for 1 month. | Dietary Supplement: Non-fortified bread<br>* Daily consumption of non-fortified bread<br>* Other names: Les Grands Moulins de Dakar;Dietary Supplement: Placebo supplement<br>* Daily intake of placebo supplement<br>* Other names: B-vitamins, DSM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma zinc concentration |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc fortification, zinc supplementation, plasma zinc concentration