Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

February 18, 2010 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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].

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Senegal
      • Dakar, Senegal
        • Helen Keller International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • apparently healthy males

Exclusion Criteria:

  • Hemoglobin <80 g/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Les Grands Moulins de Dakar
Dietary supplement: Placebo supplement
Daily intake of placebo supplement
Other Names:
  • 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 Names:
  • Les Grands Moulins de Dakar
Dietary supplement: Placebo supplement
Daily intake of placebo supplement
Other Names:
  • 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 Names:
  • Zinc sulfate and B vitamins, DSM
Dietary supplement: Non-fortified bread
Daily consumption of non-fortified bread
Other Names:
  • 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: Placebo supplement
Daily intake of placebo supplement
Other Names:
  • B-vitamins, DSM
Dietary supplement: Non-fortified bread
Daily consumption of non-fortified bread
Other Names:
  • Les Grands Moulins de Dakar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma zinc concentration
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107008-2
  • 200816610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Zinc Deficiency

Clinical Trials on Zinc-fortified bread

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe