Impact of Targeted 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 targeted 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 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 Type

Interventional

Enrollment (Actual)

98

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

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • apparently healthy

Exclusion Criteria:

  • severe malnutrition
  • severe anemia

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 group
Daily consumption of zinc-fortified complementary food
Dietary supplement: Zinc fortified food
Daily consumption
Other Names:
  • Provital, CoAID
Other: Placebo supplement
Liquid placebo supplement
Other Names:
  • B vitamins, DSM
Placebo Comparator: Non-fortified group
Daily consumption of non-fortified complementary food and placebo supplement.
Other: Placebo supplement
Liquid placebo supplement
Other Names:
  • B vitamins, DSM
Dietary supplement: Non-fortified food
Non-fortified complementary food.
Other Names:
  • Provital, CoAID
Experimental: Zinc supplement group
Daily consumption of zinc supplement and non-fortified complementary food.
Dietary supplement: Non-fortified food
Non-fortified complementary food.
Other Names:
  • Provital, CoAID
Dietary supplement: Zinc supplement
Liquid supplement containing zinc sulfate
Other Names:
  • Zinc sulfate and B vitamins, DSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma zinc concentration
Time Frame: 3 weeks
3 weeks

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

January 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

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

  • 200817275
  • 107008

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.

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