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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin A Status With Maize Feeding

Intervention / Treatment
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* Other: Orange maize feeding
* Other: Vitamin A supplement
* Other: Oil only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 57 Months
Maximum Age: 88 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange maize<br>Children were fed orange maize and the intervention name was orange | Other: Orange maize feeding<br>* This group was fed orange maize.<br>|
| Active Comparator: Blue vitamin A group<br>Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment. | Other: Vitamin A supplement<br>* This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.<br>|
| Placebo Comparator: White<br>Received oil only at the same volume as the vitamin A group | Other: Oil only<br>* This group received a small amount of plain oil without vitamin A.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin A status changes | Vitamin A status is measured before and after the intervention. | After the intervention, which is approximately 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.