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Impact of Mass 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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00944723
Enrollment
132
Registered
2009-07-23
Start date
2009-08-31
Completion date
2010-02-28
Last updated
2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Keywords

zinc fortification, zinc supplementation, plasma zinc concentration

Brief summary

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

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 \[positive control group\].

Interventions

DIETARY_SUPPLEMENTNon-fortified bread

Daily consumption of non-fortified bread

DIETARY_SUPPLEMENTPlacebo supplement

Daily intake of placebo supplement

DIETARY_SUPPLEMENTZinc-fortified bread

Bread made with zinc-fortified wheat flour

DIETARY_SUPPLEMENTZinc supplement

Liquid supplement with zinc

Sponsors

Helen Keller International
CollaboratorOTHER
Cheikh Anta Diop University, Senegal
CollaboratorOTHER
Global Alliance for Improved Nutrition
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* apparently healthy males

Exclusion criteria

* Hemoglobin \<80 g/L

Design outcomes

Primary

MeasureTime frame
Plasma zinc concentration1 month

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026