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

Not Applicable

Completed

• Conditions: Nutritional Deficiency
• Interventions: Other: Fortified Maize; Other: Biofortified Maize; Other: Control Maize

• Registration Number: NCT02208635
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study Start: 2012-10
• Primary Completion: 2014-01
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortified Maize	Fortified Maize	Participants in this arm were fed zinc-oxide fortified maize (total level of \~60 µg Zn/g).
Biofortified Maize	Biofortified Maize	Participants in this arm were fed zinc biofortified maize (\~30 µg Zn/g).
Control Maize	Control Maize	Participants in this arm were fed maize that was not fortified or biofortified (\~15 µg Zn/g maize).

Primary Outcome Measures

Name	Time	Method
Absorption of zinc	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).

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

University Teaching Hospital; 🇿🇲 Lusaka, Zambia