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

NCT02363985 | Completed DMC

• 1 other identifier: EPHI_IAEA_P6047
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of infectious diseases and malnutrition is the most prevalent, preventable public health problem in the world, responsible for millions of deaths annually, particularly in infants and children. Approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. 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. 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. However, circulating concentrations of serum retinol are reduced by infections and in such situations serum retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins can indicate the severity and duration of an infection. Correcting vitamin A deficiency is addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most area of the country. 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.

Conditions

Vitamin A Deficiency

Outcome Measures

Primary Outcomes (3)

• Total body pool size vitamin A (µmol)

  estimate the total body pool size vitamin A in preschool child in Ethiopia using stable isotope technique

  within the coming 2 years

• Liver Vitamin A store (µmol/g)

  Liver Vit A store (µmol/g) cut off \<= 0.07

  within the coming 2 years

• Serum retinol (µmol/l)

  Serum retinol (µmol/l) cut off \<= 0.7

  within the coming 2 years

Secondary Outcomes (5)

• level of infection

  within the coming 2 years

• dietary intake

  within the coming 2 years

• Anthropometry measurement

  within the coming 2 years

• socioeconomic status

  within the coming 2 years

• Morbidity

  within the coming 2 years

Study Arms (2)

Multiple vitamin A exposer

OTHER

55 children who are using * Mega-dose vitamin A supplementation * Food diversification (promotion and education on vitamin A rich food consumption) * Promotion of orange flash sweet potato production and consumption in collaboration with international potato center (CIP) in one of the study area

Dietary Supplement: Mega-dose of vitamin A supplement

Only vitamin A supplementation

OTHER

55 children who are using * Mega-dose vitamin A supplementation * Food diversification (promotion and education on vitamin A rich food consumption)

Dietary Supplement: Mega-dose of vitamin A supplement

Interventions

Mega-dose of vitamin A supplement DIETARY_SUPPLEMENT

vitamin A supplementation normally given every six months for under five children in Ethiopia. In addition, there is also dietary intervention like orange flash sweet potato and promotion of other vitamin A rich foods to tackle vitamin A deficiency in Ethiopia.

Multiple vitamin A exposer; Only vitamin A supplementation

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years, planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.

You may not qualify if:

• severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.

Sponsors & Collaborators

• Ethiopian Public Health Institute: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, 1242, Ethiopia

Location

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Cornelia Loechl, PhD

  International Atomic Energy Agency

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: March 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

ET (1)