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Completed

NCT Number: NCT00944398

Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

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

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Key information

Conditions

Zinc Deficiency

Age range

12 month–17 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helen Keller International

Dakar, Senegal

About this study

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:

  • Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
  • 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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • apparently healthy

Exclusion criteria

  • severe malnutrition
  • severe anemia

Treatment and study plan

Zinc fortified food

Dietary Supplement

Daily consumption

Other names: Provital, CoAID

Zinc Supplement

Dietary Supplement

Liquid supplement containing zinc sulfate

Other names: Zinc sulfate and B vitamins, DSM

placebo supplement

Other

Liquid placebo supplement

Other names: B vitamins, DSM

Non-fortified food

Dietary Supplement

Non-fortified complementary food.

Other names: Provital, CoAID

Primary outcomes

  1. Plasma zinc concentration

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Cheikh Anta Diop University, Senegal
  • Global Alliance for Improved Nutrition
  • Helen Keller International

Registry information

Official study title

Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2009
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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