The current WHO/UNICEF recommended daily dose of iron for program settings where the prevalence of anemia is greater than 40% is 12.5 mg of iron (based on ferrous sulfate), for infants and young children from 6-24 months of age. Sprinkles are a new multiple micronutrient approach to home-fortification of complementary foods for children containing iron as microencapsulated ferrous fumarate. The dose of iron in Sprinkles should be large enough to treat anemia within a relatively short period of time yet be safe for prophylactic use in non-anemic children.The objectives of the study is to evaluate and compare the initial hematologic response from three different doses of Sprinkles, and two forms of iron compared to the reference standard (ferrous sulfate drops) in anemic infants 6-18 months of age.
The design of the study will involve randomizing anemic infants to one of 5 groups: (1)12.5, (2) 20, or (3) 30 mg Fe in the form of microencapsulated ferrous fumarate Sprinkles; or (4) 20 mg Fe in the form of ferric pyrophosphate Sprinkles; or (5) 1 mL ferrous sulfate drops equivalent to 15 mg Fe as the positive control group. Hemoglobin, ferritin and transferrin receptor will be measured after 3 weeks and at the end of the intervention at 2 months to assess change in iron status.
This study is being funded by The Canadian Institutes of Health Research (CIHR)