Iron and Vitamin A in School Children (IronVitA)

University Ghent

Status: Completed

Conditions: Cognitive Development; Vitamin A Deficiency; Anemia, Iron Deficiency; Helminthic Infection

Treatments: Other: High-dose Vitamin A supplement; Other: Intermittent placebo iron supplement; Other: Intermittent iron supplement; Other: Placebo Vitamin A

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04137354

EC/2019/1289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 504 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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504 participants in 4 patient groups, including a placebo group

Control Iron&Vitamin A Placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo Vitamin A

Other: Intermittent placebo iron supplement

Vitamin A & Placebo Iron Supplements

Experimental group

Description:

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)

Treatment:

Other: Intermittent placebo iron supplement

Other: High-dose Vitamin A supplement

Intermittent Iron Supplements & Placebo Vitamin A

Experimental group

Description:

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).

Treatment:

Other: Placebo Vitamin A

Other: Intermittent iron supplement

Intermittent Iron Supplements & High dose Vitamin A

Experimental group

Description:

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).

Treatment:

Other: Intermittent iron supplement

Other: High-dose Vitamin A supplement