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

NCT ID: NCT02208635

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Nutritional Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Biofortified Maize

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

Group Type: EXPERIMENTAL

Biofortified Maize

Intervention Type: OTHER

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

Fortified Maize

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

Group Type: EXPERIMENTAL

Fortified Maize

Intervention Type: OTHER

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

Control Maize

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

Group Type: ACTIVE_COMPARATOR

Control Maize

Intervention Type: OTHER

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

Interventions

Biofortified Maize

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

Intervention Type: OTHER

Fortified Maize

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

Intervention Type: OTHER

Control Maize

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role: collaborator

HarvestPlus

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hambidge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University Teaching Hospital

Lusaka, , Zambia

Countries

United States; Zambia

References

Chomba E, Westcott CM, Westcott JE, Mpabalwani EM, Krebs NF, Patinkin ZW, Palacios N, Hambidge KM. Zinc absorption from biofortified maize meets the requirements of young rural Zambian children. J Nutr. 2015 Mar;145(3):514-9. doi: 10.3945/jn.114.204933. Epub 2015 Jan 21.

Reference Type: RESULT

PMID: 25733467 (View on PubMed)

Other Identifiers

14-1126

Identifier Type: -

Identifier Source: org_study_id