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Kinetics of Retinol and TBS Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their TBS and Those of Their Infants

NCT05604248 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-11-10

No results posted yet for this study

Summary

Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed.

The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.

Conditions

  • Vitamin A

Interventions

OTHER

Intervention

Mother : 2.0 μmol 13C2 -retinyl acetate diluted in soybean oil Children : 1.0 μmol 13C2 -retinyl acetate diluted in soybean oil

Sponsors & Collaborators

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • Cheikh Anta Diop University, Senegal

    lead OTHER

Principal Investigators

  • Pernille Kaestel, PhD · International Atomic Energy Agency

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-04-08
Completion
2023-07-08

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604248 on ClinicalTrials.gov