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

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin A Status With Maize Feeding

Intervention: Orange maize feeding (Other); Vitamin A supplement (Other); Oil only (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Wisconsin, Madison

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Primary outcome: Vitamin A status changes

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.

Eligibility

Minimum age: 57 Months. Maximum age: 88 Months. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: May 2012
Last updated: March 19, 2013

Page last updated: August 23, 2015

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