search
Back to results

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

Primary Purpose

Infection, Vitamin A Overdose

Status
Completed
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Vitamin A supplementation
Sponsored by
Cheikh Anta Diop University, Senegal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infection focused on measuring Vitamin A Status, Retinol Isotope dilution, Total body vitamin A stores, Children, Senegal

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universite Cheikh Anta Diop

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin A supplementation

Arm Description

55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health

Outcomes

Primary Outcome Measures

Vitamin A status 1
Total body pool size vitamin A (mmol)

Secondary Outcome Measures

Acute infection
C-reactive protein (CRP) expressed as mg/L
Chronic infection
Acide glycoprotein (AGP) expressed as g/L
Iron status
Ferritin expressed as µg/L
Stunting
Height for Age Z-score
Wasting
Weight for Height Z-score and middle upper arm circumference
Underweight
Weight for Age Z-score,
Morbidity
Medical 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.
Socioeconomic status
Quintile 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 intake
24h dietary recall and food consumption frequency
Anemia status
Hemoglobin expressed as g/L
Malaria parasitemia
Presence or absence of plasmodium falciparum antigens

Full Information

First Posted
January 24, 2017
Last Updated
February 22, 2019
Sponsor
Cheikh Anta Diop University, Senegal
Collaborators
International Atomic Energy Agency
search

1. Study Identification

Unique Protocol Identification Number
NCT03207308
Brief Title
Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status
Official Title
Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Senegal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cheikh Anta Diop University, Senegal
Collaborators
International Atomic Energy Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Vitamin A Overdose
Keywords
Vitamin A Status, Retinol Isotope dilution, Total body vitamin A stores, Children, Senegal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A supplementation
Arm Type
Experimental
Arm Description
55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A supplementation
Intervention Description
200,000 IU of preformed vitamin A
Primary Outcome Measure Information:
Title
Vitamin A status 1
Description
Total body pool size vitamin A (mmol)
Time Frame
Within the coming 2 years
Secondary Outcome Measure Information:
Title
Acute infection
Description
C-reactive protein (CRP) expressed as mg/L
Time Frame
Within the coming 2 years
Title
Chronic infection
Description
Acide glycoprotein (AGP) expressed as g/L
Time Frame
Within the coming 2 years
Title
Iron status
Description
Ferritin expressed as µg/L
Time Frame
Within the coming 2 years
Title
Stunting
Description
Height for Age Z-score
Time Frame
Within the coming 2 years
Title
Wasting
Description
Weight for Height Z-score and middle upper arm circumference
Time Frame
Within the coming 2 years
Title
Underweight
Description
Weight for Age Z-score,
Time Frame
Within the coming 2 years
Title
Morbidity
Description
Medical 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.
Time Frame
Within the coming 2 years
Title
Socioeconomic status
Description
Quintile 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.)
Time Frame
Within the coming 2 years
Title
Dietary intake
Description
24h dietary recall and food consumption frequency
Time Frame
Within the coming 2 years
Title
Anemia status
Description
Hemoglobin expressed as g/L
Time Frame
Within the coming 2 years
Title
Malaria parasitemia
Description
Presence or absence of plasmodium falciparum antigens
Time Frame
Within the coming 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Loechl, PhD
Organizational Affiliation
International Atomic Energy Agency
Official's Role
Study Director
Facility Information:
Facility Name
Universite Cheikh Anta Diop
City
Dakar
Country
Senegal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs