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Completed

NCT Number: NCT00944723

Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

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

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Key information

Conditions

Zinc Deficiency

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Helen Keller International

Dakar, Senegal

About this study

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:

  • Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
  • 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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • apparently healthy males

Exclusion criteria

  • Hemoglobin <80 g/L

Treatment and study plan

Zinc-fortified bread

Dietary Supplement

Bread made with zinc-fortified wheat flour

Other names: Les Grands Moulins de Dakar

Zinc Supplement

Dietary Supplement

Liquid supplement with zinc

Other names: Zinc sulfate and B vitamins, DSM

Non-fortified bread

Dietary Supplement

Daily consumption of non-fortified bread

Other names: Les Grands Moulins de Dakar

Placebo supplement

Dietary Supplement

Daily intake of placebo supplement

Other names: B-vitamins, DSM

Primary outcomes

  1. Plasma zinc concentration

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Cheikh Anta Diop University, Senegal
  • Global Alliance for Improved Nutrition
  • Helen Keller International

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2009
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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