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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00944398
Other study ID # 200817275
Secondary ID 107008
Status Completed
Phase Phase 4
First received July 21, 2009
Last updated February 18, 2010
Start date January 2009
Est. completion date October 2009

Study information

Verified date February 2010
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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].


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date October 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 17 Months
Eligibility Inclusion Criteria:

- apparently healthy

Exclusion Criteria:

- severe malnutrition

- severe anemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Zinc fortified food
Daily consumption
Zinc supplement
Liquid supplement containing zinc sulfate
Other:
Placebo supplement
Liquid placebo supplement
Dietary Supplement:
Non-fortified food
Non-fortified complementary food.

Locations

Country Name City State
Senegal Helen Keller International Dakar

Sponsors (4)

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

Country where clinical trial is conducted

Senegal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma zinc concentration 3 weeks No
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