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

NCT06759493 | Recruiting DMC

• 1 other identifier: RID_VAB
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin A Deficiency; Inflammation

Keywords

Vitamin A; School; children; Isotope; Burkina Faso

Outcome Measures

Primary Outcomes (1)

• Vitamin A status

  Blood vitamin A concentration and liver Vitamin A reserves

  3 years

Study Arms (3)

the modified relative dose response (MRDR) female

female participants who will receive a single dose of 3,4-didehydroretinyl acetate

Diagnostic Test: Retinol isotope dilution technique

the modified relative dose response (MRDR) Male

Male participants who will receive a single dose of 3,4-didehydroretinyl acetate

Diagnostic Test: Retinol isotope dilution technique

retinol isotope dilution (RID)

Participants who will be tested with retinol isotope dilution technique. These participants will receive a single dose of 13C2-retinyl acetate

Interventions

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.

Also known as: Modified relative dose response (MRDR) test, 3,4-didehydroretinyl acetate in oil

the modified relative dose response (MRDR) Male; the modified relative dose response (MRDR) female

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso: lead
• International Atomic Energy Agency (IAEA): collaborator

Study Sites (1)

IRSS-DRO

Bobo-Dioulasso, Bobo-Dioulasso, Houet, Région Des hauts-Bassins, Burkina Faso

RECRUITING

Related Publications (13)

• Williams AM, Tanumihardjo SA, Rhodes EC, Mapango C, Kazembe B, Phiri F, Kang'ombe DD, Sheftel J, Orchardson V, Tripp K, Suchdev PS. Vitamin A deficiency has declined in Malawi, but with evidence of elevated vitamin A in children. Am J Clin Nutr. 2021 Apr 6;113(4):854-864. doi: 10.1093/ajcn/nqab004.

  PMID: 33751046 BACKGROUND

• Barua AB, Ghosh MC. Preparation and properties of 4-oxo-retinoic acid and its methylester. Tetrahedron Lett. Pergamon; 1972;13:1823-5.

  BACKGROUND

• Bationo JF, Zeba AN, Abbeddou S, Coulibaly ND, Sombier OO, Sheftel J, Bassole IHN, Barro N, Ouedraogo JB, Tanumihardjo SA. Serum Carotenoids Reveal Poor Fruit and Vegetable Intake among Schoolchildren in Burkina Faso. Nutrients. 2018 Oct 4;10(10):1422. doi: 10.3390/nu10101422.

  PMID: 30287727 BACKGROUND

• Bationo JF, Zeba AN, Coulibaly ND, Sheftel J, Davis CR, N Bassole IH, Barro N, Ouedraogo JB, Tanumihardjo SA. Liver retinol estimated by 13C-retinol isotope dilution at 7 versus 14 days in Burkinabe schoolchildren. Exp Biol Med (Maywood). 2019 Nov;244(16):1430-1437. doi: 10.1177/1535370219877132. Epub 2019 Sep 23.

  PMID: 31547685 BACKGROUND

• Filteau SM, Morris SS, Abbott RA, Tomkins AM, Kirkwood BR, Arthur P, Ross DA, Gyapong JO, Raynes JG. Influence of morbidity on serum retinol of children in a community-based study in northern Ghana. Am J Clin Nutr. 1993 Aug;58(2):192-7. doi: 10.1093/ajcn/58.2.192.

  PMID: 8338047 BACKGROUND

• Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.

  PMID: 25411289 BACKGROUND

• Gannon BM, Valentine AR, Davis CR, Howe JA, Tanumihardjo SA. Duration of Retinol Isotope Dilution Studies with Compartmental Modeling Affects Model Complexity, Kinetic Parameters, and Calculated Vitamin A Stores in US Women. J Nutr. 2018 Aug 1;148(8):1387-1396. doi: 10.1093/jn/nxy095.

  PMID: 30137477 BACKGROUND

• Howe JA, Valentine AR, Hull AK, Tanumihardjo SA. 13C natural abundance in serum retinol acts as a biomarker for increases in dietary provitamin A. Exp Biol Med (Maywood). 2009 Feb;234(2):140-7. doi: 10.3181/0806-RM-199. Epub 2008 Dec 30.

  PMID: 19116317 BACKGROUND

• Sheftel J, Tanumihardjo SA. Systematic Review and Meta-Analysis of the Relative Dose-Response Tests to Assess Vitamin A Status. Adv Nutr. 2021 Jun 1;12(3):904-941. doi: 10.1093/advances/nmaa136.

  PMID: 33130884 BACKGROUND

• Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.

  PMID: 26447158 BACKGROUND

• Suri DJ, Wirth JP, Adu-Afarwuah S, Petry N, Rohner F, Sheftel J, Tanumihardjo SA. Inflammation Adjustments to Serum Retinol and Retinol-Binding Protein Improve Specificity but Reduce Sensitivity when Estimating Vitamin A Deficiency Compared with the Modified Relative Dose-Response Test in Ghanaian Children. Curr Dev Nutr. 2021 Jul 15;5(8):nzab098. doi: 10.1093/cdn/nzab098. eCollection 2021 Aug.

  PMID: 34386690 BACKGROUND

• Tanumihardjo SA, Barua AB, Olson JA. Use of 3,4-didehydroretinol to assess vitamin A status in rats. Int J Vitam Nutr Res. 1987;57(2):127-32.

  PMID: 3654104 BACKGROUND

• Thurnham DI, McCabe GP, Northrop-Clewes CA, Nestel P. Effects of subclinical infection on plasma retinol concentrations and assessment of prevalence of vitamin A deficiency: meta-analysis. Lancet. 2003 Dec 20;362(9401):2052-8. doi: 10.1016/s0140-6736(03)15099-4.

  PMID: 14697804 BACKGROUND

MeSH Terms

Conditions

Vitamin A Deficiency; Inflammation

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Augustin N. ZEBA, PhD

  Institut de Recherche en Sciences de la Santé

  PRINCIPAL INVESTIGATOR

• Sherry A. TANUMIHARDJO, PhD

  University of Madison - Wisconsin

  STUDY CHAIR

Central Study Contacts

Augustin N ZEBA, Maître de Recherche

CONTACT

+22672168697; nawidzeba@gmail.com

Lea N. PARE/ TOE, Maitre de recherche

CONTACT

+22620981880; lea_toe@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: November 21, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

BU (1)