InfectionNCT03207308
Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status
A study testing Vitamin A supplementation in people with Infection and Vitamin A Overdose, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Vitamin A Overdose
- What is being tested?
- Vitamin A supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSenegal
- Study dates
- 3 Feb 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Senegal
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.
Read the 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.
- Conditions
- Infection, Vitamin A Overdose
- Being tested
- Vitamin A supplementation
- Keywords
- Vitamin A Status, Retinol Isotope dilution, Total body vitamin A stores, Children, Senegal
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementationDietary supplement
200,000 IU of preformed vitamin A
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A supplementation | Experimental | 55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health Receives: Dietary Supplement: Vitamin A supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A status 1
Total body pool size vitamin A (mmol)
Measured: Within the coming 2 years
Secondary outcomes (11)
Acute infection
C-reactive protein (CRP) expressed as mg/L
Measured: Within the coming 2 years
Chronic infection
Acide glycoprotein (AGP) expressed as g/L
Measured: Within the coming 2 years
Iron status
Ferritin expressed as µg/L
Measured: Within the coming 2 years
Stunting
Height for Age Z-score
Measured: Within the coming 2 years
Wasting
Weight for Height Z-score and middle upper arm circumference
Measured: Within the coming 2 years
Underweight
Weight for Age Z-score,
Measured: Within the coming 2 years
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.
Measured: Within the coming 2 years
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.)
Measured: Within the coming 2 years
Dietary intake
24h dietary recall and food consumption frequency
Measured: Within the coming 2 years
Anemia status
Hemoglobin expressed as g/L
Measured: Within the coming 2 years
Malaria parasitemia
Presence or absence of plasmodium falciparum antigens
Measured: Within the coming 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start3 Feb 2017
- Primary completion15 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheikh Anta Diop University, Senegal
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Cornelia Loechl, PhD, Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207308
- Sponsor's protocol ID
- RAF6047SEN
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Senegal
- ClinicalTrials.gov ID
- NCT03207308
- Acronym / sponsor ID
- RAF6047SEN
- Conditions
- Infection, Vitamin A Overdose
- Keywords
- Vitamin A Status, Retinol Isotope dilution, Total body vitamin A stores, Children, Senegal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cheikh Anta Diop University, SenegalUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin A supplementation | Experimental | Dietary Supplement: Vitamin A supplementation55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A supplementation200,000 IU of preformed vitamin A | Dietary supplement | Vitamin A supplementation |
Primary outcome
Vitamin A status 1
Time frame: Within the coming 2 years
Total body pool size vitamin A (mmol)
11 secondary outcomes
Acute infection
Time frame: Within the coming 2 years
Chronic infection
Time frame: Within the coming 2 years
Iron status
Time frame: Within the coming 2 years
Stunting
Time frame: Within the coming 2 years
Wasting
Time frame: Within the coming 2 years
Underweight
Time frame: Within the coming 2 years
Morbidity
Time frame: Within the coming 2 years
Socioeconomic status
Time frame: Within the coming 2 years
Dietary intake
Time frame: Within the coming 2 years
Anemia status
Time frame: Within the coming 2 years
Malaria parasitemia
Time frame: Within the coming 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia Loechl, PhD study director
International Atomic Energy Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A supplementation in people with Infection and Vitamin A Overdose, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin A status 1 (time frame: Within the coming 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.