Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

Phase 4

Completed

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

• Registration Number: NCT00944398
• 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 targeted 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 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 \[positive control group\].

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• apparently healthy

Exclusion Criteria

• severe malnutrition
• severe anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc fortified group	Zinc fortified food	Daily consumption of zinc-fortified complementary food
Zinc fortified group	Placebo supplement	Daily consumption of zinc-fortified complementary food
Non-fortified group	Non-fortified food	Daily consumption of non-fortified complementary food and placebo supplement.
Non-fortified group	Placebo supplement	Daily consumption of non-fortified complementary food and placebo supplement.
Zinc supplement group	Zinc supplement	Daily consumption of zinc supplement and non-fortified complementary food.
Zinc supplement group	Non-fortified food	Daily consumption of zinc supplement and non-fortified complementary food.

Primary Outcome Measures

Name	Time	Method
Plasma zinc concentration	3 weeks

Trial Locations

Locations (1)

Helen Keller International; 🇸🇳 Dakar, Senegal