Iron and Vitamin A in School Children

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

• Flemish Interuniversity Council (VLIR)

  collaborator NETWORK

• Arba Minch University

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Stefaan De Henauw, Md. PhD · University Ghent

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

7 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-02

Primary Completion

2021-12-28

Completion

2021-12-28

Countries

• Ethiopia

Study Locations