Assessment of Vitamin A Status of ChildrenNCT03194724
Using Stable Isotope Techniques to Monitor & Assess the Vitamin A Status of Children Susceptible to Infection
An observational study of Assessment of Vitamin A Status of Children, run by National Food Technology Research Centre, Botswana.
Trial summary
The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Assessment of Vitamin A Status of Children
- What is being tested?
- Vitamin A supplementation
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2016to 31 Dec 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Child
Study population: The project will include preschool children 3-5 years of age. This age has been selected given the high risk of vitamin A deficiency in young children, as well as national policy for biannual vitamin A supplementation of preschool children. Children younger than 3 will not be included due to the volume of blood needed for biomarker analysis. Recruitment will be done in various settings, including household-level, clinics/hospitals, and childcare centres.
Who may be able to join
- Children will be included if they are in the target age range (3-5 years), are not planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrolment
Who cannot join
- Exclusion criteria will generally include the following conditions: severe anaemia, severe acute malnutrition, obesity, or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
About this study
The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption, nutrient loss or increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L.
Read the detailed description
Vitamin A is an essential nutrient needed for the visual system, and maintenance of cell function for growth, epithelial integrity, red blood cell production, immunity and reproduction. All infants are born with low stores and depend on vitamin A from breast milk to initially accumulate and maintain adequate stores. Infants of vitamin A depleted women are at greater risk of becoming vitamin A deficient early in life, especially if they are not breast fed. Correcting vitamin A deficiency is addressed by some African countries through vitamin A supplementation of children and food fortification programs. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores. Thus, this technique can be used for assessing vitamin A status in populations at risk of excessive status due to exposure to too much vitamin A through combined supplementation and consumption of fortified foods and/or preformed vitamin A-rich foods. The aim of this project is to use nuclear techniques to evaluate vitamin A nutritional status of young children during semi-annual administration of vitamin A supplements, and to assess how this relates to infection status. The IAEA has provided significant support on use of stable isotopes in assessing body composition and breast milk to Member States in Africa, it is now establishing the stable isotope technique to assess vitamin A body stores in Cameroon and Zambia (and additional implementation is possible in Morocco) for use throughout the region. These inputs will be used in this project to provide key information to stakeholders on how vitamin A intervention programs affect vitamin A status in children and how infections affect vitamin A status or validity of stable isotope techniques.
- Being tested
- Vitamin A supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementationOther
Bi annual vitamin A supplementation programme
| Study group | Role | What they receive |
|---|---|---|
| High Vitamin A exposure | There was no intervention Receives: Other: Vitamin A supplementation | |
| Low vitamin A exposure | No intervention Receives: Other: Vitamin A supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional vitamin A status
Vitamin A status determination using stable isotopes
Measured: 1 year
Secondary outcomes (1)
Assessment of the presence of clinical infections
Infections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start30 Apr 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Vitamin A Status of ChildrenStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Food Technology Research Centre, Botswana
- Sponsor type
- Other government
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, UNICEF, University of Botswana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194724
- Sponsor's protocol ID
- RAF 6047
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared for pooling purposes as this study is part of a regional project
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Stable Isotope Techniques to Monitor & Assess the Vitamin A Status of Children Susceptible to Infection
- ClinicalTrials.gov ID
- NCT03194724
- Acronym / sponsor ID
- RAF 6047
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Food Technology Research Centre, BotswanaOther government
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, UNICEF, University of Botswana
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 21 Jun 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.
The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity leading to increased susceptibility to infections, more frequent and prolonged disease episodes, and increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption, nutrient loss or increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or more of a defined population has a serum retinol concentration of less than 0.7 µmol/L.
Detailed description
Vitamin A is an essential nutrient needed for the visual system, and maintenance of cell function for growth, epithelial integrity, red blood cell production, immunity and reproduction. All infants are born with low stores and depend on vitamin A from breast milk to initially accumulate and maintain adequate stores. Infants of vitamin A depleted women are at greater risk of becoming vitamin A deficient early in life, especially if they are not breast fed. Correcting vitamin A deficiency is addressed by some African countries through vitamin A supplementation of children and food fortification programs. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries. Evaluation of vitamin A status is relatively insensitive when based on changes in serum retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin A status. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum of deficient to excessive stores. Thus, this technique can be used for assessing vitamin A status in populations at risk of excessive status due to exposure to too much vitamin A through combined supplementation and consumption of fortified foods and/or preformed vitamin A-rich foods. The aim of this project is to use nuclear techniques to evaluate vitamin A nutritional status of young children during semi-annual administration of vitamin A supplements, and to assess how this relates to infection status. The IAEA has provided significant support on use of stable isotopes in assessing body composition and breast milk to Member States in Africa, it is now establishing the stable isotope technique to assess vitamin A body stores in Cameroon and Zambia (and additional implementation is possible in Morocco) for use throughout the region. These inputs will be used in this project to provide key information to stakeholders on how vitamin A intervention programs affect vitamin A status in children and how infections affect vitamin A status or validity of stable isotope techniques.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Vitamin A exposure | – | Other: Vitamin A supplementationThere was no intervention |
| Low vitamin A exposure | – | Other: Vitamin A supplementationNo intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The project will include preschool children 3-5 years of age. This age has been selected given the high risk of vitamin A deficiency in young children, as well as national policy for biannual vitamin A supplementation of preschool children. Children younger than 3 will not be included due to the volume of blood needed for biomarker analysis. Recruitment will be done in various settings, including household-level, clinics/hospitals, and childcare centres.
Key inclusion criteria (1 listed)
- Children will be included if they are in the target age range (3-5 years), are not planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrolment
Key exclusion criteria (1 listed)
- Exclusion criteria will generally include the following conditions: 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 supplementationBi annual vitamin A supplementation programme | Other | High Vitamin A exposure, Low vitamin A exposure |
Primary outcome
Cross sectional vitamin A status
Time frame: 1 year
Vitamin A status determination using stable isotopes
1 secondary outcome
Assessment of the presence of clinical infections
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: Yes. Data will be shared for pooling purposes as this study is part of a regional project
Related trials for Assessment of Vitamin A Status of Children
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Serum Vitamin D Status in Critically Ill Children With Acute Respiratory Infections
Acute Respiratory Infections, Critical Illness in Children
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of Vitamin A Status of Children, run by National Food Technology Research Centre, Botswana.
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: status not confirmed, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Cross sectional vitamin A status (time frame: 1 year). 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 21 Jun 2017.