Iron and Vitamin A in School Children
Condition: Anemia, Iron Deficiency; Vitamin A Deficiency; Cognitive Development; Helminthic Infection
MeSH terms: Helminthiasis; Night Blindness; Anemia, Iron-Deficiency; Iron Deficiencies; Vitamin A Deficiency
Study type: Interventional

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.
    

Intervention name(s): Intermittent placebo iron supplement; Intermittent iron supplement; Placebo Vitamin A; High-dose Vitamin A supplement
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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); 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); 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).; 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 intervention name(s): Control iron; Experimental iron; Control Vitamin A; Experimental Vitamin A
Intervention MeSH terms: Vitamins; Vitamin A; Iron; Retinol palmitate
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: In randomized placebo-control trial eligible primary school children in the Arba Minch HDSS will be randomly assigned to four groups of treatment in a factorial 2x2 design:
A control placebo receiving placebo vitamin A at baseline and after 5 months, and placebo iron supplement weekly;
A high dose vitamin A at baseline and after 5 months and weekly placebo iron supplement;
Weekly iron supplementation for 10 months and placebo vitamin A at baseline and after 5 months;
Combined weekly iron supplementation and high dose vitamin A at baseline and after 5 months.
At the end of the study, and if the results are positive, children who receive the placebo iron supplement will receive weekly iron supplementation (42mg of elemental iron once a week) for 10 months. Children in all the treatment groups remain eligible to benefit from the standard health care and nutrition programs provided at school, such as deworming at the beginning of the school year
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intermittent Iron supplementation; Vitamin A; Cognitive Development; Anemia