Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months (HPZM)

April 26, 2016 updated by: University of Colorado, Denver
The objective of this study is to compare the quantity of Zn absorbed from an accurately weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual food staple is maize.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participating children were randomized to receive an accurately weighed quantity of ~100g/day of either the control, fortified or biofortified study maize for 1 day.

On day 1, mothers brought their child to the health center before breakfast. All meals were extrinsically labeled with a zinc stable isotope (70Zn). Meals on this day were consumed in the presence of the research staff. The quantities of nshima or porridge prepared and eaten were accurately weighed and duplicate meals were collected for subsequent mineral analyses.

Between lunch and dinner on day 1 at the Health Center, a blood sample was collected for Hb and plasma Zn analyses and, immediately after and through the same needle, a stable isotope of zinc was intravenously administered into a forearm vein over 1-2 minutes. The family then returned home.

Morning spot urine samples were collected twice daily starting on day 5 and continuing through day 8. Once these collections were finished, the study for this child was complete.

Dietary Zn was measured from laboratory assays of the duplicate test meals. Fractional absorption of Zn (FAZ) was measured by dual isotope tracer ratio methods in urine. Absorbed Zn was calculated by multiplying dietary Zn by FAZ.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
  • Zambia
      • Lusaka, Zambia
        • University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children age 24 to 36 months
  • Maize meal accounts for at least 75% energy intake
  • Able to consume 100 g maize flour/day
  • Clinically healthy (stunting is acceptable)
  • Lives in target community

Exclusion Criteria:

  • Children with chronic or other known chronic disease
  • If children are receiving zinc-fortified products, these products will need to be withheld for 2 weeks prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofortified Maize
Participants in this arm were fed zinc biofortified maize (~30 µg Zn/g).
Other: Biofortified Maize
Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).
Experimental: Fortified Maize
Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).
Other: Fortified Maize
Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).
Active Comparator: Control Maize
Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).
Other: Control Maize
Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorption of zinc
Time Frame: 1 day
Absorption of zinc will be measured in young children fed a diet of control, Zn-biofortified, or Zn-fortified maize. Fractional absorption of zinc from all meals of the day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

University Teaching Hospital, Lusaka, Zambia
HarvestPlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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