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

University of Wisconsin (UW)

Status: Completed

Conditions: Vitamin A Status With Maize Feeding

Treatments: Other: Orange maize feeding; Other: Oil only; Other: Vitamin A supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01814891

Zambia II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 57 to 88 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 3 patient groups, including a placebo group

Orange maize

Experimental group

Description:

Children were fed orange maize and the intervention name was "orange"

Treatment:

Other: Orange maize feeding

Blue vitamin A group

Active Comparator group

Description:

Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment.

Treatment:

Other: Vitamin A supplement

White

Placebo Comparator group

Description:

Received oil only at the same volume as the vitamin A group

Treatment:

Other: Oil only