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 | Unknown

• 1 other identifier: E43035
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin A status; Retinol isotope dilution technique; compartmental modeling; Wonder women; 13C2-Retinyl acetate; Senegal

Outcome Measures

Primary Outcomes (1)

• Vitamin A status

  Total body store vitamin A (µmol)

  Within the coming 2 years

Study Arms (1)

Lactating mother-infant pair

OTHER

8 arms of 7 lactating women for a total of 56 women following a study design integrating a model-based compartmental analysis with the Retinol Isotope Dilution (RID) technique using a "Wonder women" approach. For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28.

Other: Intervention

Interventions

Intervention OTHER

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

Also known as: Stable isotope

Lactating mother-infant pair

Eligibility Criteria

• Age: 9 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For mothers: Willing to participate in the study and to give 4 blood and 4 milk samples during the whole duration of the study, Being aged 18-45 years, Not planning to travel during the study duration
• For children: Being aged 9-18 months, Being breastfed, Mother willing to authorize 2 bloods, Do not receive vitamin A supplements during the study

You may not qualify if:

• For mothers: Being pregnant, Consuming vitamin A and/or effector supplements, Smoke or drink alcohol during the study period
• For children: Have received a vitamin A supplement in the two months prior to the study
• All: Had fever or any obviously known or clinical diagnosed disease, malaria positive, severe anemia, severe acute malnutrition or severe obesity, being hemophiliac

Sponsors & Collaborators

• Cheikh Anta Diop University, Senegal: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Universite Cheikh Anta Diop

Dakar, 10700, Senegal

Location

MeSH Terms

Interventions

Methods; Isotope Labeling

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Pernille Kaestel, PhD

  International Atomic Energy Agency

  STUDY DIRECTOR

Central Study Contacts

Nicole Idohou-Dossou,, Pr

CONTACT

775691311; nicole.dossou@ucad.edu.sn

Adama Diouf, Pr

CONTACT

776459651; adama.diouf@ucad.edu.sn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 3, 2022
• Study Start: April 1, 2023
• Primary Completion: April 8, 2023
• Study Completion: July 8, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)