Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

This study has been completed.
Sponsor:
Collaborators:
Helen Keller International
Cheikh Anta Diop University, Senegal
Global Alliance for Improved Nutrition
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944398
First received: July 21, 2009
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Zinc Deficiency
Dietary Supplement: Zinc fortified food
Dietary Supplement: Zinc supplement
Other: Placebo supplement
Dietary Supplement: Non-fortified food
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma zinc concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc fortified group
Daily consumption of zinc-fortified complementary food
Dietary Supplement: Zinc fortified food
Daily consumption
Other Name: Provital, CoAID
Other: Placebo supplement
Liquid placebo supplement
Other Name: B vitamins, DSM
Placebo Comparator: Non-fortified group
Daily consumption of non-fortified complementary food and placebo supplement.
Other: Placebo supplement
Liquid placebo supplement
Other Name: B vitamins, DSM
Dietary Supplement: Non-fortified food
Non-fortified complementary food.
Other Name: Provital, CoAID
Experimental: Zinc supplement group
Daily consumption of zinc supplement and non-fortified complementary food.
Dietary Supplement: Zinc supplement
Liquid supplement containing zinc sulfate
Other Name: Zinc sulfate and B vitamins, DSM
Dietary Supplement: Non-fortified food
Non-fortified complementary food.
Other Name: Provital, CoAID

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].
  Eligibility

Ages Eligible for Study:   12 Months to 17 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • apparently healthy

Exclusion Criteria:

  • severe malnutrition
  • severe anemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944398

Locations
Senegal
Helen Keller International
Dakar, Senegal
Sponsors and Collaborators
University of California, Davis
Helen Keller International
Cheikh Anta Diop University, Senegal
Global Alliance for Improved Nutrition
Investigators
Principal Investigator: Kenneth H Brown, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Prof. Kenneth H. Brown, Helen Keller International
ClinicalTrials.gov Identifier: NCT00944398     History of Changes
Other Study ID Numbers: 200817275, 107008
Study First Received: July 21, 2009
Last Updated: February 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Zinc fortification
Plasma zinc concentration
Assessment of zinc status

Additional relevant MeSH terms:
Vitamins
Zinc
Vitamin B Complex
Zinc Sulfate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Trace Elements
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014