Drug intelligence / Profile preview

iron sulphate + folic acid

Development stage
Phase 4
Lead developer
National Institute of Child Health and Human Development
Modality
Small Molecules
Administration
Oral
01

Overview

This is an investigational nutritional supplement combination consisting of iron sulphate (providing 12.5 mg of elemental iron) and folic acid (50 μg). It was evaluated by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the Nepal Nutrition Intervention Project-Sarlahi (NNIPS-4), a Phase 3 community-based, cluster-randomized trial (NCT00109551). The study aimed to assess the impact of daily supplementation on mortality and morbidity in children aged 1-35 months in rural Nepal. Formulated as dispersible tablets by Nutriset, the intervention was designed to address iron and folate deficiencies common in young children in low-resource settings. However, the iron-folic acid arm of the trial was terminated early in November 2003 following a recommendation from the Data Safety and Monitoring Board, as the supplement did not demonstrate a significant reduction in all-cause mortality compared to placebo.

Other names
iron sulphate-folic acid dietary supplementiron-folic acidIFA

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