- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194724
Using Stable Isotope Techniques to Monitor & Assess the Vitamin A Status of Children Susceptible to Infection
June 19, 2017 updated by: National Food Technology Research Centre, Botswana
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
120
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High Vitamin A exposure
There was no intervention
|
Bi annual vitamin A supplementation programme
|
Low vitamin A exposure
No intervention
|
Bi annual vitamin A supplementation programme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross sectional vitamin A status
Time Frame: 1 year
|
Vitamin A status determination using stable isotopes
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the presence of clinical infections
Time Frame: 1 year
|
Infections
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 30, 2016
Primary Completion (ANTICIPATED)
December 31, 2017
Study Completion (ANTICIPATED)
December 31, 2018
Study Registration Dates
First Submitted
June 19, 2017
First Submitted That Met QC Criteria
June 19, 2017
First Posted (ACTUAL)
June 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 19, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAF 6047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared for pooling purposes as this study is part of a regional project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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