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Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT00944398
Collaborator
Helen Keller International (Other), Cheikh Anta Diop University, Senegal (Other), Global Alliance for Improved Nutrition (Other)
98
Enrollment
1
Location
3
Arms
9
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Zinc fortified food
  • Dietary Supplement: Zinc supplement
  • Other: Placebo supplement
  • Dietary Supplement: Non-fortified food
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
98 participants
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
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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: Zinc supplement
    Liquid supplement containing zinc sulfate
    Other Names:
  • Zinc sulfate and B vitamins, DSM

    • Dietary Supplement: Non-fortified food
    Non-fortified complementary food.
    Other Names:
  • Provital, CoAID

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma zinc concentration [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 17 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • apparently healthy
    Exclusion Criteria:

    • severe malnutrition

    • severe anemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00944398
    Other Study ID Numbers:
    • 200817275
    • 107008
    First Posted:
    Jul 23, 2009
    Last Update Posted:
    Feb 19, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Zinc fortification
    Plasma zinc concentration
    Assessment of zinc status
    Additional relevant MeSH terms:
    Vitamins
    Zinc
    Vitamin B Complex
    Zinc Sulfate

    Study Results

    No Results Posted as of Feb 19, 2010