Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

University of California (UC) Davis

Status and phase: Completed; Phase 4

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: Non-fortified bread; Dietary Supplement: Zinc-fortified bread; Dietary Supplement: Zinc supplement; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00944723

200816610

107008-2

Details and patient eligibility

About

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

Full 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].

Enrollment: 132 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• apparently healthy males

Exclusion criteria

• Hemoglobin <80 g/L

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

Zinc-fortified bread (10 mg zinc/d)

Experimental group

Description:

Daily consumption of zinc fortified bread for 1 month

Treatment:

Dietary Supplement: Placebo supplement

Dietary Supplement: Zinc-fortified bread

Zinc fortified bread (20 mg zinc/d)

Experimental group

Description:

Daily consumption of zinc fortified bread for 1 month.

Treatment:

Dietary Supplement: Placebo supplement

Dietary Supplement: Zinc-fortified bread

Zinc supplemented group

Experimental group

Description:

Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)

Treatment:

Dietary Supplement: Zinc supplement

Dietary Supplement: Non-fortified bread

Non-fortified group

Placebo Comparator group

Description:

Daily consumption of non-fortified bread and a placebo supplement for 1 month.

Treatment:

Dietary Supplement: Placebo supplement

Dietary Supplement: Non-fortified bread