Impact of Targeted 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 targeted 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 young children. The following specific steps will be completed: Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology. A two-week feeding trial will be implemented to assess the change in plasma zinc concentration among young children who receive: a) the zinc-fortified cereal porridge and a liquid vitamin preparation between meals; b) a non-zinc-fortified cereal porridge and a liquid vitamin preparation between meals [negative control group]; or c) a non-zinc-fortified cereal porridge 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 food
* Dietary Supplement: Zinc supplement
* Other: Placebo supplement
* Dietary Supplement: Non-fortified food


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: apparently healthy Exclusion Criteria: severe malnutrition severe anemia

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 17 Months

Sexes Eligible for Study
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All

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 group<br>Daily consumption of zinc-fortified complementary food | Dietary Supplement: Zinc fortified food<br>* Daily consumption<br>* Other names: Provital, CoAID;Other: Placebo supplement<br>* Liquid placebo supplement<br>* Other names: B vitamins, DSM;|
| Placebo Comparator: Non-fortified group<br>Daily consumption of non-fortified complementary food and placebo supplement. | Other: Placebo supplement<br>* Liquid placebo supplement<br>* Other names: B vitamins, DSM;Dietary Supplement: Non-fortified food<br>* Non-fortified complementary food.<br>* Other names: Provital, CoAID;|
| Experimental: Zinc supplement group<br>Daily consumption of zinc supplement and non-fortified complementary food. | Dietary Supplement: Zinc supplement<br>* Liquid supplement containing zinc sulfate<br>* Other names: Zinc sulfate and B vitamins, DSM;Dietary Supplement: Non-fortified food<br>* Non-fortified complementary food.<br>* Other names: Provital, CoAID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma zinc concentration |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc fortification, Plasma zinc concentration, Assessment of zinc status