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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Nutritional Deficiency

Treatments: Other: Control Maize; Other: Fortified Maize; Other: Biofortified Maize

Study type: Interventional

Funder types: Other

Identifiers

NCT02208635

14-1126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 24 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Biofortified Maize

Experimental group

Description:

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

Treatment:

Other: Biofortified Maize

Fortified Maize

Experimental group

Description:

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

Treatment:

Other: Fortified Maize

Control Maize

Active Comparator group

Description:

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

Treatment:

Other: Control Maize