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Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children

Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01814891
Enrollment
143
Registered
2013-03-20
Start date
2012-05-31
Completion date
2012-10-31
Last updated
2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Status With Maize Feeding

Keywords

vitamin A, maize, total body reserves, Condition is vitamin A status., Focus: change in vitamin A status with maize feeding., Focus: feeding orange maize to children for 90 days., Focus: total body reserves of vitamin A.

Brief summary

Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.

Detailed description

This study will determine the change in total body stores of vitamin A in response to feeding orange maize for 90 days. This will be compared to two other groups of children that are fed white maize, one of which will get a vitamin A supplement at the estimated average requirement.

Interventions

OTHEROrange maize feeding

This group was fed orange maize.

This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.

OTHEROil only

This group received a small amount of plain oil without vitamin A.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
57 Months to 88 Months
Healthy volunteers
Yes

Inclusion criteria

1. Children aged 57-88 months at the time of initiation of the study 2. Children living in the locality defined by the study and not enrolled in school. 3. Consent from parent/guardian.

Exclusion criteria

1. Severely malnourished children (weight for age or height z-scores \<-3 standard deviations below the WHO growth reference standards) 2. Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening 3. Children whose families plan to leave the study area before completion of the study 4. Consent not obtained from parent/guardian 5. Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian 6. Children with severe anemia (Hb \<7.0 g/dL) as determined at the baseline blood draw.

Design outcomes

Primary

MeasureTime frameDescription
Vitamin A status changesAfter the intervention, which is approximately 3 months.Vitamin A status is measured before and after the intervention.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026