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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944398

Enrollment

Registered

2009-07-23

Start date

2009-01-31

Completion date

2009-10-31

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, Plasma zinc concentration, Assessment of zinc status

Brief summary

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted 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 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 \[positive control group\].

Interventions

DIETARY_SUPPLEMENTZinc fortified food

Daily consumption

DIETARY_SUPPLEMENTZinc supplement

Liquid supplement containing zinc sulfate

OTHERPlacebo supplement

Liquid placebo supplement

DIETARY_SUPPLEMENTNon-fortified food

Non-fortified complementary food.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 17 Months

Healthy volunteers

Yes

Inclusion criteria

* apparently healthy

Exclusion criteria

* severe malnutrition * severe anemia

Design outcomes

Primary

Measure	Time frame
Plasma zinc concentration	3 weeks

Countries

Senegal

Outcome results

None listed

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