CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 504 enrolled
Drug / intervention
Intermittent placebo iron supplement +3 moreother
Likely dose
Not stated in record
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Search/NCT04137354
NCT04137354N/ACompleted

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

University Ghent·interventional·Posted Oct 24, 2019·Updated Mar 3, 2023

In Brief

A clinical study evaluating Intermittent placebo iron supplement, Intermittent iron supplement, and 2 other interventions for Anemia, Iron Deficiency and 3 related conditions. Completed, enrolled 504 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEthiopia

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 24, 2019
Enrollment StartNov 2, 2020
Primary CompletionDec 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.7 years ago

Interventions

Intermittent placebo iron supplementother

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)

Intermittent iron supplementother

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)

Placebo Vitamin Aother

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).

High-dose Vitamin A supplementother

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).