Safe and Efficacious Iron for Children in Kenya
Condition: Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      Background: Fortification of local complementary foods and supplementation with micronutrient
      powders including iron has been shown to prevent anaemia. Iron can cause complaints
      (diarrhoea, constipation, etc.) related to oxidative stress in the intestine, however, and at
      doses conventionally used for daily supplementation, iron can increase rates of malaria and
      diarrhoea. A lower dose of iron (3mg/day) as NaFEEDTA can reduce these adverse effects whilst
      having similar or superior efficacy in improving iron status as conventional-dose iron
      (12.5mg) as ferrous salts.

      Objective: The primary aim is to compare daily home fortification with 3mg iron as NaFeEDTA
      versus 12.5 mg iron as encapsulated ferrous fumarate regarding haemoglobin concentration at
      the end of the 30-day fortification period.

      Methods: Rural children aged 12-36 months (n=324) will receive albendazole and praziquantel
      against helminth infections, and preventive chemotherapy against malaria with
      dihydroartemisinin-piperaquine. They will subsequently be randomised to daily home
      fortification for 30 days with sachets containing either a) 3 mg iron as NaFeEDTA; b) 12.5 mg
      iron as encapsulated ferrous fumarate; or c) placebo. Parents or guardians will be instructed
      to mix the contents of the sachets with solid or semi-solid, ready-prepared foods. Adherence
      will be assessed by an electronic monitoring and time-recording device in the cap of a
      dispensing bottle containing the sachets. At the end of the 30-day fortification period, a
      venous blood sample will be collected to measure indicators of iron status and inflammation.
      Children who received iron will continue to be followed for a maximum of 120 days after
      randomisation to estimate the time point when ≥10% of children has developed severe anaemia
      (haemoglobin concentration <70 g/L).
    

Intervention name(s): Low-dose iron as NaFeEDTA; Conventional dose iron as ferrous salt; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily home fortification for 30 days with 3 mg iron as NaFeEDTA, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate); Daily home fortification for 30 days with 12.5 mg iron as encapsulated ferrous fumarate, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate); Daily home fortification for 30 days with vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)
Intervention MeSH terms: Iron; Fe(III)-EDTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iron; Anemia; Sodium Fe(III)-ethylenediaminetetraacetic acid (NaFeEDTA); Ferrous compounds; Child, preschool; Kenya