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NCT Number: NCT04137354

Iron and Vitamin A in School Children

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Intermittent placebo iron supplement

Other

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

Intermittent iron supplement

Other

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

Placebo Vitamin A

Other

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

High-dose Vitamin A supplement

Other

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

Primary outcomes

  1. Memory span

    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

  2. Spatial exploration and awareness

    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

  3. Reasoning ability

    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

  4. Anemia

    Time frame: Hemoglobin concentrations of children will be assessed at 9 months

    Hemoglobin concentrations (g/dL)

  5. Plasma ferritin

    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

  6. Soluble transferrin receptor

    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

Secondary outcomes

  1. Serum concentrations in Vitamin A (retinol)

    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

  2. Serum concentrations in vitamin B12

    Time frame: Vitamin B12 concentrations will be assessed in all children at 9 months

    Serum concentrations in vitamin B12

  3. Prevalence of soil-transmitted helminths

    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).

  4. Prevalence of Schistosome infection

    Time frame: Prevalence of Schistosome infection will be assessed at 4.5 months and at 9 months

    The prevalence of Schistosoma mansoni infection

  5. Adherence to the iron/placebo supplements

    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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Arba Minch University
  • Flemish Interuniversity Council (VLIR)

Registry information

Official study title

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

Acronym: IronVitA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2019
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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