2) Presented at the FASB Experimental Biology conference in Orlando, Florida, 2001:
PART 1. RANDOMIZED PROSPECTIVE CONTROLLED TRIAL OF FERROUS SULFATE DROPS VERSUS MICRONENCAPSULATED FERROUS FUMARATE ‘SPRINKLES’ FOR TREATMENT OF ANEMIA IN GHANAIAN INFANTS AND YOUNG CHILDREN. Stanley Zlotkin, Paul Arthur, Kojo Yeboah Antwi, George Yeung. Dept of Paediatrics and Nutr Sci, Hosp For Sick Children, U of Toronto, Toronto, Canada M5R1L9, London School of Hygiene & Trop Med, London, UK, Kintampo Health Res. Centre, Min. of Health, Ghana.>> Background: The standard therapy for anemia in infants is ferrous sulfate drops (DROPS) administered 3-times daily. Unfortunately, adherence to treatment is often poor in both developed and developing countries. One reason for the lack of success is the unpleasant side-effects associated with the use of this form of iron. AIM: In this study we evaluated the use of a new form of iron,
dosing schedule and delivery system to treat anemia in infants that is likely to produce better adherence to treatment. Methods: Using a prospective randomized controlled design, we studied 557 anemic children (age range 6-18 months; hemoglobin values 70-99 g/L) in rural Ghana. One group received a daily sachet of microencapsulated ferrous fumarate (80 mg elemental iron) plus ascorbic acid to be sprinkled on to any complementary (weaning) food (SPRINKLES); and the control group DROPS 3-times daily (total dose 40 mg elemental iron). Treatment lasted for 2 months. Hemoglobin (Hb) and serum ferritin (ferr) values were measured at baseline and end. Results: Successful treatment of anemia (Hb > 100 g/L) occurred in 58% of SPRINKLES group, and in 56% of the DROPS group (p=0.51) with minimal side-effects in both groups. Ferr levels increased significantly in each group from baseline to end (p=0.001). Conclusion Use of DROPS or SPRINKLES with ascorbic acid resulted in a similar rate of successful treatment of anemia without side effects. To our knowledge, this is the first demonstration of the use of SPRINKLES to treat anemia. Although not tested in the current study, improved adherence to treatment and ease of use may favour the use of SPRINKLES to deliver iron. Supported by a grant from USAID’s OMNI Research Program through the HNI of ILSI. Material support from Mead Johnson Canada & Nestle Canada.
Part 2. Randomized Prospective Placebo-Controlled Trial Of Microencapsulated Ferrous Fumarate ‘Sprinkles’ With And Without Vitamin A And Ferrous Sulfate Drops, For Prevention Of Anemia In Infants
Background Successful treatment of anemia may not reverse its negative developmental sequellae in children; thus, primary prevention should be the goal of intervention programs. Long-term prophylactic use of ferrous sulfate drops (DROPS) is not effective due to poor compliance, thus alternatives must be found. Previously, we demonstrated that DROPS or microencapsulated ferrous fumarate sprinkles (SPRINKLES) were both efficacious in treating 60% of children with anemia. Among the possible causes for the lack of response (in 40%) was vitamin A deficiency since 48% were deficient. Thus our AIM was to compare the use of SPRINKLES (with and without vitamin A) to DROPS for the prevention of anemia. Methods We studied 324 Ghanaian children (mean age 15.64±4.47 months; hemoglobin (Hb)³100 g/L) for 6 months using a prospective randomized placebo-controlled design. These previously anemic infants had received treatment with iron for 2 months prior to enrollment. Four groups included: (1) DROPS; (2) placebo sachet; (3) SPRINKLES; and (4) SPRINKLES with vitamin A. Hb and ferritin
(FERR) values were measured at baseline and end. Results Among the 4 groups, there were no significant differences in mean Hb values (112.2 ±14.7g/L, p=0.70) or FERR (median=62.8 range=0.0-363.6mg/L) from baseline to the end. During the trial, 82.4% maintained their non-anemic status. Sprinkles were well accepted without complications. Conclusions In previously treated infants, there is no need for further intervention to prevent anemia at least for 6 months. These results have important implications for iron intervention programs in developing countries where initial treatment may be necessary because of a high prevalence of anemia. Supported by USAID’s OMNI Research Program through the HNI of ILSI. Material support from Mead Johnson Canada & Nestle Canada.