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

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ClinicalTrials.gov Identifier: NCT02363985
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
International Atomic Energy Agency
Information provided by (Responsible Party):
Tesfaye Hailu, Ethiopian Public Health Institute

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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Dietary Supplement: Mega-dose of vitamin A supplement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Ethiopia
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
Multiple vitamin A exposer

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
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.

Only vitamin A supplementation

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
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.




Primary Outcome Measures :
  1. Total body pool size vitamin A (µmol) [ Time Frame: within the coming 2 years ]
    estimate the total body pool size vitamin A in preschool child in Ethiopia using stable isotope technique

  2. Liver Vitamin A store (µmol/g) [ Time Frame: within the coming 2 years ]
    Liver Vit A store (µmol/g) cut off <= 0.07

  3. Serum retinol (µmol/l) [ Time Frame: within the coming 2 years ]
    Serum retinol (µmol/l) cut off <= 0.7


Secondary Outcome Measures :
  1. level of infection [ Time Frame: within the coming 2 years ]
    AGP and CRP

  2. dietary intake [ Time Frame: within the coming 2 years ]
    mean intake of beta carotene and dietary diversity score using 24 hour dietary recall

  3. Anthropometry measurement [ Time Frame: within the coming 2 years ]
    Weight for Height Z-score, Weight for Age Z-score, Height for Age Z-score and middle upper arm circumference

  4. socioeconomic status [ Time Frame: within the coming 2 years ]
    household (HH) family size, marital status of the mother, head of the HH, source of drinking wate, highest level of education the head of HH attend

  5. Morbidity [ Time Frame: within the coming 2 years ]
    medical history of the child enrolled in the study such as diarrhea, cough, fever, malaria, rashes, measles, vaccination, vitamin A supplementation, durg for intestinal deworming, iron supplementation.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 3-5 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363985


Locations
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Ethiopia
Ethiopian Public Health Institute
Addis Ababa, Ethiopia, 1242
Sponsors and Collaborators
Ethiopian Public Health Institute
International Atomic Energy Agency
Investigators
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Study Director: Cornelia Loechl, PhD International Atomic Energy Agency

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Responsible Party: Tesfaye Hailu, Researcher, Ethiopian Public Health Institute
ClinicalTrials.gov Identifier: NCT02363985     History of Changes
Other Study ID Numbers: EPHI_IAEA_P6047
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

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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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Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
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