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Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944723
First Posted: July 23, 2009
Last Update Posted: February 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Helen Keller International
Cheikh Anta Diop University, Senegal
Global Alliance for Improved Nutrition
Information provided by:
University of California, Davis
  Purpose
The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.

Condition Intervention Phase
Zinc Deficiency Dietary Supplement: Zinc-fortified bread Dietary Supplement: Zinc supplement Dietary Supplement: Non-fortified bread Dietary Supplement: Placebo supplement Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma zinc concentration [ Time Frame: 1 month ]

Enrollment: 132
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc-fortified bread (10 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month
Dietary Supplement: Zinc-fortified bread
Bread made with zinc-fortified wheat flour
Other Name: Les Grands Moulins de Dakar
Dietary Supplement: Placebo supplement
Daily intake of placebo supplement
Other Name: B-vitamins, DSM
Experimental: Zinc fortified bread (20 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month.
Dietary Supplement: Zinc-fortified bread
Bread made with zinc-fortified wheat flour
Other Name: Les Grands Moulins de Dakar
Dietary Supplement: Placebo supplement
Daily intake of placebo supplement
Other Name: B-vitamins, DSM
Experimental: Zinc supplemented group
Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)
Dietary Supplement: Zinc supplement
Liquid supplement with zinc
Other Name: Zinc sulfate and B vitamins, DSM
Dietary Supplement: Non-fortified bread
Daily consumption of non-fortified bread
Other Name: Les Grands Moulins de Dakar
Placebo Comparator: Non-fortified group
Daily consumption of non-fortified bread and a placebo supplement for 1 month.
Dietary Supplement: Non-fortified bread
Daily consumption of non-fortified bread
Other Name: Les Grands Moulins de Dakar
Dietary Supplement: Placebo supplement
Daily intake of placebo supplement
Other Name: B-vitamins, DSM

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 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].
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • apparently healthy males

Exclusion Criteria:

  • Hemoglobin <80 g/L
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944723


Locations
Senegal
Helen Keller International
Dakar, Senegal
Sponsors and Collaborators
University of California, Davis
Helen Keller International
Cheikh Anta Diop University, Senegal
Global Alliance for Improved Nutrition
Investigators
Principal Investigator: Kenneth H Brown, MD University of California, Davis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Kenneth H. Brown, Helen Keller International
ClinicalTrials.gov Identifier: NCT00944723     History of Changes
Other Study ID Numbers: 107008-2
200816610
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: February 19, 2010
Last Verified: February 2010

Keywords provided by University of California, Davis:
zinc fortification
zinc supplementation
plasma zinc concentration

Additional relevant MeSH terms:
Vitamins
Zinc
Zinc Sulfate
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Astringents
Dermatologic Agents