Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

University of California (UC) Davis

Status and phase: Completed; Phase 4

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: Zinc supplement; Other: Placebo supplement; Dietary Supplement: Non-fortified food; Dietary Supplement: Zinc fortified food

Study type: Interventional

Funder types: Other

Identifiers

NCT00944398

107008

200817275

Details and patient eligibility

About

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted 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 young children. The following specific steps will be completed:

1. Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
2. 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].

Enrollment: 98 patients

Sex: All

Ages: 12 to 17 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• apparently healthy

Exclusion criteria

• severe malnutrition
• severe anemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 3 patient groups, including a placebo group

Zinc fortified group

Experimental group

Description:

Daily consumption of zinc-fortified complementary food

Treatment:

Dietary Supplement: Zinc fortified food

Other: Placebo supplement

Non-fortified group

Placebo Comparator group

Description:

Daily consumption of non-fortified complementary food and placebo supplement.

Treatment:

Dietary Supplement: Non-fortified food

Other: Placebo supplement

Zinc supplement group

Experimental group

Description:

Daily consumption of zinc supplement and non-fortified complementary food.

Treatment:

Dietary Supplement: Non-fortified food

Dietary Supplement: Zinc supplement