Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration

NCT ID: NCT00944398

Last Updated: 2010-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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 \[positive control group\].

Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc fortified group

Daily consumption of zinc-fortified complementary food

Group Type EXPERIMENTAL

Zinc fortified food

Intervention Type DIETARY_SUPPLEMENT

Daily consumption

Placebo supplement

Intervention Type OTHER

Liquid placebo supplement

Non-fortified group

Daily consumption of non-fortified complementary food and placebo supplement.

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type OTHER

Liquid placebo supplement

Non-fortified food

Intervention Type DIETARY_SUPPLEMENT

Non-fortified complementary food.

Zinc supplement group

Daily consumption of zinc supplement and non-fortified complementary food.

Group Type EXPERIMENTAL

Zinc supplement

Intervention Type DIETARY_SUPPLEMENT

Liquid supplement containing zinc sulfate

Non-fortified food

Intervention Type DIETARY_SUPPLEMENT

Non-fortified complementary food.

Interventions

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Zinc fortified food

Daily consumption

Intervention Type DIETARY_SUPPLEMENT

Zinc supplement

Liquid supplement containing zinc sulfate

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Liquid placebo supplement

Intervention Type OTHER

Non-fortified food

Non-fortified complementary food.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Provital, CoAID Zinc sulfate and B vitamins, DSM B vitamins, DSM Provital, CoAID

Eligibility Criteria

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Inclusion Criteria

* apparently healthy

Exclusion Criteria

* severe malnutrition
* severe anemia
Minimum Eligible Age

12 Months

Maximum Eligible Age

17 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helen Keller International

OTHER

Sponsor Role collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role collaborator

Global Alliance for Improved Nutrition

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Helen Keller International

Principal Investigators

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Kenneth H Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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Helen Keller International

Dakar, , Senegal

Site Status

Countries

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Senegal

References

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Lo NB, Aaron GJ, Hess SY, Dossou NI, Guiro AT, Wade S, Brown KH. Plasma zinc concentration responds to short-term zinc supplementation, but not zinc fortification, in young children in Senegal1,2. Am J Clin Nutr. 2011 Jun;93(6):1348-55. doi: 10.3945/ajcn.111.012278. Epub 2011 Apr 13.

Reference Type DERIVED
PMID: 21490143 (View on PubMed)

Other Identifiers

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107008

Identifier Type: -

Identifier Source: secondary_id

200817275

Identifier Type: -

Identifier Source: org_study_id

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