Arba Minch University
Arba Minch, Ethiopia
NCT Number: NCT04137354
The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing.
The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.
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Notify Me7 year–10 year
All sexes
Interventional
Not applicable
Arba Minch, Ethiopia
Iron deficiency is the commonest micronutrient deficiency worldwide and the major cause of specific anemia - iron deficiency anemia. Iron is an essential mineral with lots of functions in the human body; its deficiency is associated with cognitive impairment, emotional alteration, and altered homeostasis in myelination and neurotransmission. Vitamin A deficiency can lead to anemia, weakened resistance to infection, blindness, and death. Animal model studies showed that vitamin A could affect cognition. Cognitive skills, influenced by cognitive development of the individual, are related with academic performance of the student and long-term success. One target of the Sustainable Development Goals (SDG 4) is to ensure inclusive and equitable quality education and promote lifelong learning opportunities for all. Poor health and undernutrition of children in Low- and Middle-Income Countries (LMIC) are the major limitations to reach their potential school performance and learning skills. The evidence on the role of intermittent iron supplementation in preventing anemia is strong but several aspects of cognitive development, co-supplementation with other micronutrients such as vitamin A are missing.
The aim of this study is to evaluate the effectiveness of intermittent iron and high-dose vitamin A supplementation integrated within school nutritional plan on anemia, iron status and cognitive development of school children (7 - 10 year old) who live in areas with high rates of food insecurity in Ethiopia.
Method: The study will be carried out at primary schools in Arba Minch Zuria District, Ethiopia in children aged from 7 to 10 years. Eligible children (a total of 504 children) will be randomly assigned to one of the four groups: 1) Control placebo receiving placebo vitamin A and placebo iron supplement; 2) Vitamin A group will receive a high dose vitamin A capsule (200,000 IU) and placebo iron supplement.;3) Iron group will receive weekly iron supplementation (42 mg of elemental iron) and placebo vitamin A; and 4)Iron-vitamin A group will receive a combined weekly iron supplementation and high dose vitamin A.
Iron supplements (42mg of elemental iron)/placebo will be given to school chidlren weekly for 10 months and 200,000 IU of vitamin A/placebo will be given at baseline and after 5 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo iron supplements are also three tablets containing the same ingredients as for iron tablets and will be given to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
Other names: Control iron
Three iron tablets containing 42 mg of elemental iron will be provided to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
Other names: Experimental iron
Children will receive in a colorful Eppendorf tube 400 micro-liter of corn oil stabilized with vitamin A twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
Other names: Control Vitamin A
Children will receive in a colorful Eppendorf tube 400 micro-liter of oil-based preparation of retinyl palmitate that contains the equivalent of 100,000 IU (110μmol) of vitamin A and stabilized with 20IU of vitamin E twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
Other names: Experimental Vitamin A
Time frame: Memory span of the children will be assessed at 9 months
Digit span (forward and backward) is a standardized test that assess the working memory of the children, one indicator of cognitive development
Time frame: Spatial exploration and awareness of the children will be assessed at 9 months
Vision search using cancellation task of the children, the second indicator of cognitive development
Time frame: The reasoning ability of the children will be assessed at 9 months
Raven's colored progressive matrices, the third indicator of cognitive development
Time frame: Hemoglobin concentrations of children will be assessed at 9 months
Hemoglobin concentrations (g/dL)
Time frame: Plasma ferritin is assessed in all children at 9 months
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time frame: Soluble transferrin receptor is assessed in all children at 9 months
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time frame: Retinol concentrations will be assessed in all children at 9 months
Retinol concentrations in serum is an indicator of vitamin A status of children
Time frame: Vitamin B12 concentrations will be assessed in all children at 9 months
Serum concentrations in vitamin B12
Time frame: The prevalence of soil-transmitted helminths will be assessed at 4.5 months and at 9 months
The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).
Time frame: Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months
The prevalence of Schistosoma mansoni infection
Time frame: Weekly for the whole period of the intervention of 9 months.
Adherence to the tablets of Iron/Placebo will be assessed through teacher's reports. Teachers are the ones who are providing the supplements in a weekly basis.
University Ghent
Other
Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.
Acronym: IronVitA
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