Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Orange maize feeding

+ Vitamin A supplement

+ Oil only

Other
Who is being recruted

Keratosis+1

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 57 to 88 Months
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorUniversity of Wisconsin, Madison
Last updated: March 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01814891
Principal SponsorUniversity of Wisconsin, Madison
Last updated: March 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 57 to 88 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

KeratosisSkin DiseasesSkin and Connective Tissue DiseasesCallosities

Criteria

3 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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 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 whose families plan to leave the study area before completion of the study
Children with severe anemia (Hb < 7.0 g/dL) as determined at the baseline blood draw
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Children were fed orange maize and the intervention name was &quot;orange&quot;

Group II

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

Group III

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers