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Completed

NCT Number: NCT01814891

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

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.

Completed

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Key information

Age range

57 month–88 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severely malnourished children (weight for age or height z-scores <-3 standard deviations below the WHO growth reference standards)
  • 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
  • Children whose families plan to leave the study area before completion of the study
  • Consent not obtained from parent/guardian
  • 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
  • Children with severe anemia (Hb <7.0 g/dL) as determined at the baseline blood draw.

Treatment and study plan

Orange maize feeding

Other

This group was fed orange maize.

Vitamin A supplement

Other

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

Oil only

Other

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

Primary outcomes

  1. Vitamin A status changes

    Time frame: After the intervention, which is approximately 3 months.

    Vitamin A status is measured before and after the intervention.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2013
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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