Iron and Vitamin A in School Children
- Conditions
- Vitamin A DeficiencyAnemia, Iron DeficiencyCognitive DevelopmentHelminthic Infection
- Interventions
- Other: Intermittent iron supplementOther: Intermittent placebo iron supplementOther: Placebo Vitamin AOther: High-dose Vitamin A supplement
- Registration Number
- NCT04137354
- Lead Sponsor
- University Ghent
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
- One or both their parents signed informed consent form;
- Their parents planned to stay during the period of the study (for the full academic year) in the kebele; and
- They accept of the intervention package including blood draw and home visits. School children with severe anemia (Hb concentration <80 g/L) will be treated by conventional protocol for three months at nearby health centres. After reassessing their haemoglobin concentrations, they can be assigned to their intervention groups if they become eligible as described above.
- Chronically ill children like diagnosed diabetic and asthma
- Severely under nourished children (defined as body mass index z-score <-3 standard deviations of the median WHO reference population)
- Those who are treated for tuberculosis or suspected to have tuberculosis
- Children with diagnosed haemoglobinopathy (sickle cell and thalassemias)
- Children with night blindness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control Iron&Vitamin A Placebo Placebo Vitamin A Children randomly assigned to the placebo iron \& vitamin A control group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). Intermittent Iron Supplements & High dose Vitamin A High-dose Vitamin A supplement Combined weekly iron supplementation (42mg of elemental iron once a week) for 9 months and high dose vitamin A (200,000IU) at baseline and after 4.5 months (mid-line). Intermittent Iron Supplements & High dose Vitamin A Intermittent iron supplement Combined weekly iron supplementation (42mg of elemental iron once a week) for 9 months and high dose vitamin A (200,000IU) at baseline and after 4.5 months (mid-line). Control Iron&Vitamin A Placebo Intermittent placebo iron supplement Children randomly assigned to the placebo iron \& vitamin A control group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). Vitamin A & Placebo Iron Supplements Intermittent placebo iron supplement Children is this group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive a high dose vitamin A capsule (200,000IU) at baseline and after 4.5 months (at mid-line) Vitamin A & Placebo Iron Supplements High-dose Vitamin A supplement Children is this group will receive weekly three placebo tablets that are identical to the iron tablets (blinded) for the whole duration of the study (9 months of the school year). They will also receive a high dose vitamin A capsule (200,000IU) at baseline and after 4.5 months (at mid-line) Intermittent Iron Supplements & Placebo Vitamin A Intermittent iron supplement Children is this group will receive weekly three tablets of iron (42mg of elemental iron once a week) for 9 months (equivalent to a one school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months). Intermittent Iron Supplements & Placebo Vitamin A Placebo Vitamin A Children is this group will receive weekly three tablets of iron (42mg of elemental iron once a week) for 9 months (equivalent to a one school year). They will also receive placebo vitamin A at baseline and at mid-line (after 4.5 months).
- Primary Outcome Measures
Name Time Method Plasma ferritin 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
Memory span 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
Spatial exploration and awareness 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
Reasoning ability The reasoning ability of the children will be assessed at 9 months Raven's colored progressive matrices, the third indicator of cognitive development
Anemia Hemoglobin concentrations of children will be assessed at 9 months Hemoglobin concentrations (g/dL)
Soluble transferrin receptor 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
- Secondary Outcome Measures
Name Time Method Serum concentrations in vitamin B12 Vitamin B12 concentrations will be assessed in all children at 9 months Serum concentrations in vitamin B12
Prevalence of soil-transmitted helminths 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).
Prevalence of Schistosome infection Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months The prevalence of Schistosoma mansoni infection
Adherence to the iron/placebo supplements 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.
Serum concentrations in Vitamin A (retinol) Retinol concentrations will be assessed in all children at 9 months Retinol concentrations in serum is an indicator of vitamin A status of children
Trial Locations
- Locations (1)
Arba Minch University
🇪🇹Arba Minch, Ethiopia