Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944723
• Other study ID #: 107008-2
• Secondary ID: 200816610
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2009
• Last updated: February 18, 2010
• Start date: August 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• apparently healthy males

Exclusion Criteria:

• Hemoglobin <80 g/L

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Dietary Supplement:
• Zinc-fortified bread
Bread made with zinc-fortified wheat flour
• Zinc supplement
Liquid supplement with zinc
• Non-fortified bread
Daily consumption of non-fortified bread
• Placebo supplement
Daily intake of placebo supplement

Locations

Country	Name	City	State
Senegal	Helen Keller International	Dakar

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	Cheikh Anta Diop University, Senegal, Global Alliance for Improved Nutrition, Helen Keller International

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma zinc concentration		1 month	No