NCT04137354

Iron and Vitamin A in School Children

Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia, Iron Deficiency
• Vitamin A Deficiency
• Cognitive Development
• Helminthic Infection

Interventions

Type	Name	Description
OTHER	Intermittent placebo iron supplement	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	Intermittent iron supplement	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	Placebo Vitamin A	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	High-dose Vitamin A supplement	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).

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2019-10-24
• Last updated: 2023-03-03

Locations

1 site across 1 country: Ethiopia