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Using Stable Isotope Techniques to Monitor & Assess the Vitamin A Status of Children Susceptible to Infection

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ClinicalTrials.gov Identifier: NCT03194724
Recruitment Status : Unknown
Verified June 2017 by National Food Technology Research Centre, Botswana.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborators:
Netherlands: Ministry of Health, Welfare and Sports
UNICEF
University of Botswana
Information provided by (Responsible Party):
National Food Technology Research Centre, Botswana

Brief 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. 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.

Condition or disease Intervention/treatment
Assessment of Vitamin A Status of Children Other: Vitamin A supplementation

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Using Stable Isotope Techniques to Monitor & Assess the Vitamin A Status of Children Susceptible to Infection
Actual Study Start Date : April 30, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Group/Cohort Intervention/treatment
High Vitamin A exposure
There was no intervention
Other: Vitamin A supplementation
Bi annual vitamin A supplementation programme

Low vitamin A exposure
No intervention
Other: Vitamin A supplementation
Bi annual vitamin A supplementation programme




Primary Outcome Measures :
  1. Cross sectional vitamin A status [ Time Frame: 1 year ]
    Vitamin A status determination using stable isotopes


Secondary Outcome Measures :
  1. Assessment of the presence of clinical infections [ Time Frame: 1 year ]
    Infections



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

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Responsible Party: National Food Technology Research Centre, Botswana
ClinicalTrials.gov Identifier: NCT03194724     History of Changes
Other Study ID Numbers: RAF 6047
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared for pooling purposes as this study is part of a regional project

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents