Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration
This study has been completed.
Sponsor:
University of California, Davis
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
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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:
- Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
- 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
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 Zinc Sulfate Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Trace Elements Astringents Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013