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

Not Applicable

Completed

• Conditions: Vitamin A Status With Maize Feeding
• Interventions: Other: Orange maize feeding; Other: Vitamin A supplement; Other: Oil only

• Registration Number: NCT01814891
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Study First Posted: 2013-03-20
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orange maize	Orange maize feeding	Children were fed orange maize and the intervention name was "orange"
Blue vitamin A group	Vitamin A supplement	Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment.
White	Oil only	Received oil only at the same volume as the vitamin A group

Primary Outcome Measures

Name	Time	Method
Vitamin A status changes	After the intervention, which is approximately 3 months.	Vitamin A status is measured before and after the intervention.