Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

This study has been completed.
Sponsor:
Collaborators:
Helen Keller International
Cheikh Anta Diop University, Senegal
Global Alliance for Improved Nutrition
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944398
First received: July 21, 2009
Last updated: February 18, 2010
Last verified: February 2010

July 21, 2009
February 18, 2010
January 2009
September 2009   (final data collection date for primary outcome measure)
Plasma zinc concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944398 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration
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.

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].
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Zinc Deficiency
  • Dietary Supplement: Zinc fortified food
    Daily consumption
    Other Name: Provital, CoAID
  • Dietary Supplement: Zinc supplement
    Liquid supplement containing zinc sulfate
    Other Name: Zinc sulfate and B vitamins, DSM
  • Other: Placebo supplement
    Liquid placebo supplement
    Other Name: B vitamins, DSM
  • Dietary Supplement: Non-fortified food
    Non-fortified complementary food.
    Other Name: Provital, CoAID
  • Experimental: Zinc fortified group
    Daily consumption of zinc-fortified complementary food
    Interventions:
    • Dietary Supplement: Zinc fortified food
    • Other: Placebo supplement
  • Placebo Comparator: Non-fortified group
    Daily consumption of non-fortified complementary food and placebo supplement.
    Interventions:
    • Other: Placebo supplement
    • Dietary Supplement: Non-fortified food
  • Experimental: Zinc supplement group
    Daily consumption of zinc supplement and non-fortified complementary food.
    Interventions:
    • Dietary Supplement: Zinc supplement
    • Dietary Supplement: Non-fortified food
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
October 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • apparently healthy

Exclusion Criteria:

  • severe malnutrition
  • severe anemia
Both
12 Months to 17 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT00944398
200817275, 107008
No
Prof. Kenneth H. Brown, Helen Keller International
University of California, Davis
  • Helen Keller International
  • Cheikh Anta Diop University, Senegal
  • Global Alliance for Improved Nutrition
Principal Investigator: Kenneth H Brown, MD University of California, Davis
University of California, Davis
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP