NCT02208635

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

August 1, 2014

Last Update Submit

April 26, 2016

Conditions

Nutritional Deficiency

Keywords

Zinc AbsorptionBiofortificationMaizeZambiaStable isotopes of Zn

Outcome Measures

Primary Outcomes (1)

  • Absorption of zinc

    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

Study Arms (3)

Biofortified Maize

EXPERIMENTAL

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

Other: Biofortified Maize

Fortified Maize

EXPERIMENTAL

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

Other: Fortified Maize

Control Maize

ACTIVE COMPARATOR

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

Other: Control Maize

Interventions

Biofortified MaizeOTHER

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

Biofortified Maize
Fortified MaizeOTHER

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

Fortified Maize
Control MaizeOTHER

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

Control Maize

Eligibility Criteria

Age24 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

  • 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.

    PMID: 25733467RESULT

MeSH Terms

Conditions

MalnutritionCallosities

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Hambidge, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 5, 2014

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

ZA(1)US(1)