Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration
NCT ID: NCT00944398
Last Updated: 2010-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
98 participants
INTERVENTIONAL
2009-01-31
2009-10-31
Brief Summary
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Detailed Description
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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 \[positive control group\].
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Zinc fortified group
Daily consumption of zinc-fortified complementary food
Zinc fortified food
Daily consumption
Placebo supplement
Liquid placebo supplement
Non-fortified group
Daily consumption of non-fortified complementary food and placebo supplement.
Placebo supplement
Liquid placebo supplement
Non-fortified food
Non-fortified complementary food.
Zinc supplement group
Daily consumption of zinc supplement and non-fortified complementary food.
Zinc supplement
Liquid supplement containing zinc sulfate
Non-fortified food
Non-fortified complementary food.
Interventions
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Zinc fortified food
Daily consumption
Zinc supplement
Liquid supplement containing zinc sulfate
Placebo supplement
Liquid placebo supplement
Non-fortified food
Non-fortified complementary food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* severe anemia
12 Months
17 Months
ALL
Yes
Sponsors
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Helen Keller International
OTHER
Cheikh Anta Diop University, Senegal
OTHER
Global Alliance for Improved Nutrition
OTHER
University of California, Davis
OTHER
Responsible Party
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Helen Keller International
Principal Investigators
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Kenneth H Brown, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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Helen Keller International
Dakar, , Senegal
Countries
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References
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Lo NB, Aaron GJ, Hess SY, Dossou NI, Guiro AT, Wade S, Brown KH. Plasma zinc concentration responds to short-term zinc supplementation, but not zinc fortification, in young children in Senegal1,2. Am J Clin Nutr. 2011 Jun;93(6):1348-55. doi: 10.3945/ajcn.111.012278. Epub 2011 Apr 13.
Other Identifiers
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107008
Identifier Type: -
Identifier Source: secondary_id
200817275
Identifier Type: -
Identifier Source: org_study_id
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