Validation and Simplification of the Retinol Isotope Dilution Technique in Burkinabe Schoolchildren

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-12
SponsorInstitut de Recherche en Sciences de la Sante, Burkina Faso

About this trial

Two cross-sectional, repeated-pass, community-based studies will be carried out during the school year. The first study will be conducted from November to December. This period corresponds to the end of the rainy season and the end of the mango season, which is one of the main sources of vitamin A in the Orodara region.

The second survey will be carried out 5 to 6 months (April-May of the following year) after data collection for the first study, corresponding to the mango season. The same schoolchildren recruited during the first phase of data collection (5 to 6 months earlier) will be the participants in the second study. The interest of this study is to use nuclear techniques to implement a strategy for the precise and accurate determination of Vitamin A status in order to reinforce existing Vitamin A interventions and policies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

School children aged 7-12 years

Child's guardian or parent is willing to provide informed consent

Child's family plans to remain resident in the study areas during the study period

Disqualifiers

Clinical evidence of vitamin A deficiency a mis en forme : Anglais (Royaume-Uni)a mis en forme : Anglais (États-Unis)a mis en forme : Anglais (États-Unis)a mis en forme : Anglais (États-Unis)

Severe malnutrition (weight-for age Z score (WAZ) or height-for-age Z score (HAZ) <-3 SD)

Serious illnesses including tuberculosis, symptomatic HIV infection

Child aged <6 years or >12 years

Trial population

The proposed study will be carried out in a primary school in the Western part of Burkina Faso, in Orodara, a village at the outer edge of Bobo Dioulasso, where we will target children aged 7 to 12 years. Most inhabitants of the village are middle-income farmers and their families.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Retinol isotope dilution technique

    Diagnostic test

    A group of 60 school children will be recruited through a stratified sampling. To this first group of 60 school children a retinol isotope dilution (RID) test for total body store assessment will be applied. The remaining 98 school children will be recruited according to stratified sampling and divided into two groups of 49 children (females and males). To these groups of children, the modified relative dose response (MRDR) test, a qualitative measure of vitamin A status will be used to investigate the absorption of 3,4-didehydroretinyl acetate in oil.

Treatment groups

158 Participants
are divided into 3 treatment groups
Group A: the modified relative dose response (MRDR) female1 intervention
Group B: the modified relative dose response (MRDR) Male1 intervention
Group C: retinol isotope dilution (RID)0 interventions

Trial outcomes

Primary outcomes

1

Vitamin A status

Blood vitamin A concentration and liver Vitamin A reserves

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut de Recherche en Sciences de la Sante, Burkina Faso

Lead sponsor

International Atomic Energy Agency (IAEA)

Collaborator