Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Serum retinol (µmol/l)
研究概览
简要总结
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.
详细描述
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 species 32.1%, followed by hookworm 21.7%.
Forty seven subjects (26 male and 21 female) met the survey definition of smear positive tuberculosis (TB) cases, with a prevalence of 108/100,000 (72-138). From smear positive TB cases, 37(78.7%) were new cases, 2(4.3%) were on treatment, and 8(17%) were previously treated in the last five years. Malaria prevalence is 4.5% in the malaria endemic area.
Evaluation of Vitamin A status is relatively insensitive when based on changes in serum retinol, which is homeostatically controlled and negatively affected by subclinical infections. Liver stores of vitamin A are the best indicator of vitamin A status, but cannot be routinely evaluated. The isotope dilution technique is the preferred method for determining vitamin A status and assessing the efficiency and effectiveness of intervention programs. It is the only indirect assessment method that provides a quantitative estimate of vitamin A status across the continuum from deficient to excessive vitamin A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
研究组 & 干预措施
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)
干预措施: Mega-dose of vitamin A supplement (Dietary Supplement)
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
干预措施: Mega-dose of vitamin A supplement (Dietary Supplement)
结局指标
主要结局
Serum retinol (µmol/l)
时间窗: within the coming 2 years
Serum retinol (µmol/l) cut off \<= 0.7
Total body pool size vitamin A (µmol)
时间窗: 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)
时间窗: within the coming 2 years
Liver Vit A store (µmol/g) cut off \<= 0.07
次要结局
- Anthropometry measurement(within the coming 2 years)
- socioeconomic status(within the coming 2 years)
- level of infection(within the coming 2 years)
- dietary intake(within the coming 2 years)
- Morbidity(within the coming 2 years)
研究者
Tesfaye Hailu
Researcher
Ethiopian Public Health Institute
