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

March 19, 2013 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zambia II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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