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

Nutritional Deficiency Clinical Trial

— HPZM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208635
• Other study ID #: 14-1126
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: April 26, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Months to 36 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency

Intervention

Other:
• Biofortified Maize
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).
• Control Maize
Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
Zambia	University Teaching Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	HarvestPlus, University Teaching Hospital, Lusaka, Zambia

Countries where clinical trial is conducted

United States,  Zambia, 

References & 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No