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Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status

Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Senegal

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03207308
Enrollment
55
Registered
2017-07-02
Start date
2017-02-03
Completion date
2017-12-01
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Vitamin A Overdose

Keywords

Vitamin A Status, Retinol Isotope dilution, Total body vitamin A stores, Children, Senegal

Brief summary

Despite economic growth in developing countries, Sub-Saharan Africa still faces food insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases still remain a public health problem and have a negative impact on health and the economy. They are both directly and indirectly responsible for children morbidity and mortality. Due to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was implemented in Senegal since 1999. A national representative study undertook in 2010 to have biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale oil fortification was launched by government and private industries also fortified bouillon cubes. Furthermore, home fortification is being initiated without evaluation of VAD control strategies existing in the country. In order to assess the impact of national VAD control strategies in Senegalese children, this study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin A total body stores in relation to their infectious status.

Detailed description

Specifics objectives are: Assess total body vitamin A stores and hepatic reserves before and after vitamin A supplementation in children aged 3-5 y by deuterated-retinol dilution technique Measure plasma retinol, ferritin and zinc concentrations in children Measure plasma C-reactive protein and alpha 1 glycoprotein concentrations and malaria parasitemia Identify health, socioeconomic and food determinants that can influence children micronutrient status Study design is longitudinal with repeated measures and will be implemented in rural area. Five months after the passage of Vitamin A Supplementation (VAS) campaign, fifty children (n=50) aged 3-5y will be enrolled in the study (randomized sampling) plus 10% for drop out. The protocol will be explained to the mother and written consent will be obtained from her. Dietary intake information will be collected using 24 hour recall questionnaire, food frequency questionnaire and infections frequency questionnaire will be submitted to the mother at d-7. Anthropometric measurements (weight and height) of children will be recorded also at d-7. Subjects will receive doses of labeled vitamin A: 6µmol of D4-Vitamin A, and 6 µmol of D8-Vitamin A per children at d0 and d44 respectively. Blood sampling will be done 3 times during the study: at Baseline (d-7) and 2 weeks after each dose of labeled vitamin A (d14 and d58). The blood will be drawn from children and immediately wrapped on aluminum foil and placed in a cooler while in the field. The blood samples will be transported to the lab and treated under dim light (centrifugate and separation in cryogenic vials). C - reactive protein (CRP) and alpha-1 acid glycoprotein (AGP) will be measured by Elisa method. Serum retinol measurement will be done by HPLC after ethanol hexane extraction with 200 µl of serum and vitamin A total body stores by GC-MS. Others micronutrient determination will be done as Iron (ferritin by Enzyme Linked Fluorescent Assay (ELFA)) and Zn (Atomic Absorption Spectrophotometer by flame). Anemia will be assessed by measuring hemoglobin (Hb) in whole blood using a HemoCue system (Hb-301) and malaria parasitemia will be measured using Rapid Diagnostic tests (RDT) Statistical analyses will be carried out with STATA / SE (Special Edition, Stata Corporation, Texas, USA). The results will be expressed as mean ± standard deviation and percentages. The variables with non Gaussian distributions will undergo a logarithmic transformation and will be expressed in geometric mean ± standard deviation. The analysis of variance (ANOVA) associated with a posteriori test (Bonferroni) will be used for repeated measures and Student's t test will be used for comparison of means. The Chi² test will be used for percentages comparison. The relationship between quantitative variables will be assessed with the Pearson correlation coefficient. Multiple and logistic regression will be performed to identify the socio-economic, health and dietary determinants of vitamin A status, evaluate their contributions and their influence on the risk of vitamin A deficiency. For all these statistical analysis, a significance level of 0.05 will be applied.

Interventions

DIETARY_SUPPLEMENTVitamin A supplementation

200,000 IU of preformed vitamin A

Sponsors

International Atomic Energy Agency
CollaboratorOTHER_GOV
Cheikh Anta Diop University, Senegal
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* 3-5 years, not planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.

Exclusion criteria

* severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.

Design outcomes

Primary

MeasureTime frameDescription
Vitamin A status 1Within the coming 2 yearsTotal body pool size vitamin A (mmol)

Secondary

MeasureTime frameDescription
Chronic infectionWithin the coming 2 yearsAcide glycoprotein (AGP) expressed as g/L
Iron statusWithin the coming 2 yearsFerritin expressed as µg/L
StuntingWithin the coming 2 yearsHeight for Age Z-score
WastingWithin the coming 2 yearsWeight for Height Z-score and middle upper arm circumference
UnderweightWithin the coming 2 yearsWeight for Age Z-score,
Acute infectionWithin the coming 2 yearsC-reactive protein (CRP) expressed as mg/L
Socioeconomic statusWithin the coming 2 yearsQuintile of poverty (obtained by aggregation of socioeconomic informations like household (HH) family size, marital status of the head of the HH, source of drinking water, highest level of education the head of HH, etc.)
Dietary intakeWithin the coming 2 years24h dietary recall and food consumption frequency
Anemia statusWithin the coming 2 yearsHemoglobin expressed as g/L
Malaria parasitemiaWithin the coming 2 yearsPresence or absence of plasmodium falciparum antigens
MorbidityWithin the coming 2 yearsMedical history of the child enrolled in the study such as diarrhea, fever, malaria, rashes, measles, respiratory infection, vitamin A supplementation, drug for intestinal de-worming, iron supplementation.

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026