Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial (SEICK)

NCT02073149 Phase 2/Phase 3 COMPLETED

This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.

Details

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	338
Start date	2014-06
Completion	2014-12

Conditions

• Anaemia

Interventions

• Low-dose iron as NaFeEDTA
• Conventional dose iron as ferrous salt
• Placebo

Primary outcomes

• Hemoglobin concentration — End of the 30-day fortification period

Countries

Kenya