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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Ethiopia

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 b

Detailed Summary:

Vitamin A deficiency is the leading cause of preventable blindness in children and is associated with a higher risk of under five mortality. Approximately 250,000 to 500,000 children in developing countries become blind each year owing to vitamin A deficiency, with the highest prevalence in South Asia and Africa. In Africa, many countries have implemented vitamin A interventions of mega-dose supplementation for children under 5 years, sometimes in combination with food fortification programs.

Vitamin A deficiency is a major nutritional concern; with more than 37.7% of under five children being vitamin A deficient by serum retinol and 50.7% had been sick in the previous 15 days in Ethiopia. Vitamin A deficiency is addressed in the country through vitamin A supplementation every six months for 6-59 months of children and during the first 45 days of delivery for lactating mothers. There are also other vitamin A intervention programs like bio-fortification of orange flesh sweet potato (OFSP) in pocket areas. Unfortunately, assessing vitamin A status, and the effectiveness of government interventions, is challenging in settings where infectious diseases are endemic, as in most African countries including Ethiopia. This is because serum retinol concentration decreases during infection due to the acute phase response.

The overall national prevalence of any helminthes infection in Ethiopia was 29.8% with variable degree of prevalence among regions, where by southern nation nationality people (SNNP) (51%) and Gambella (51%) have the highest prevalence. A survey in 13 foods for education program-supported schools in the SNNP region indicated that prevalence of soil transmitted helminthiasis infections are 44.4%. The proportion of school children infected with any parasite species was 55.4%. A. lumbricoides was the most prevalent spe
Sponsor: Ethiopian Public Health Institute

Current Primary Outcome:

  • 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
  • Liver Vitamin A store (µmol/g) [ Time Frame: within the coming 2 years ]
    Liver Vit A store (µmol/g) cut off <= 0.07
  • Serum retinol (µmol/l) [ Time Frame: within the coming 2 years ]
    Serum retinol (µmol/l) cut off <= 0.7


Original Primary Outcome: Total body store vitamin A [ Time Frame: within the coming 2 years ]

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


Current Secondary Outcome:

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


Original Secondary Outcome:

  • level of infection [ Time Frame: within the coming 2 years ]
    AGP and CRP
  • dietary assessment [ Time Frame: within the coming 2 years ]
    mean intake of beta carotene and dietary diversity score
  • Anthropometry measurement [ Time Frame: within the coming 2 years ]
    WHZ, WAZ, HAZ, BMI, BAZ
  • socioeconomic status [ Time Frame: within the coming 2 years ]
  • total liver store vitamin A [ Time Frame: within the coming 2 years ]
  • serum retinol concentration [ Time Frame: within the coming 2 years ]


Information By: Ethiopian Public Health Institute

Dates:
Date Received: February 10, 2015
Date Started: November 2015
Date Completion: December 2016
Last Updated: February 14, 2015
Last Verified: February 2015