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

NCT03194724 | Unknown

• 1 other identifier: RAF 6047
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Assessment of Vitamin A Status of Children

Outcome Measures

Primary Outcomes (1)

• Cross sectional vitamin A status

  Vitamin A status determination using stable isotopes

  1 year

Secondary Outcomes (1)

• Assessment of the presence of clinical infections

  1 year

Study Arms (2)

High Vitamin A exposure

There was no intervention

Other: Vitamin A supplementation

Low vitamin A exposure

No intervention

Other: Vitamin A supplementation

Interventions

Vitamin A supplementation OTHER

Bi annual vitamin A supplementation programme

High Vitamin A exposure; Low vitamin A exposure

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• National Food Technology Research Centre, Botswana: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator
• UNICEF: collaborator
• University of Botswana: collaborator

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: April 30, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share