Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

Zinc Deficiency Clinical Trial

Official title:

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

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

• Zinc Deficiency

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