Impact of Mass 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:
NCT00944723
First received: July 21, 2009
Last updated: February 18, 2010
Last verified: February 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Plasma zinc concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • apparently healthy males

Exclusion Criteria:

  • Hemoglobin <80 g/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of California, Davis

Additional 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
Study First Received: July 21, 2009
Last Updated: February 18, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Vitamin B Complex
Vitamins
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 30, 2014