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Completed

NCT Number: NCT02208635

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

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.

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Key information

Age range

24 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofortified maize

Other

Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).

Fortified Maize

Other

Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).

Control Maize

Other

Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • HarvestPlus
  • University Teaching Hospital, Lusaka, Zambia

Registry information

Acronym: HPZM

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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