Study 1: Efficacy of Sprinkles to treat anemia (Completed)
A clinical trial testing the efficacy of Sprinkles in treating iron deficiency anemia (IDA) was conducted in Ghana where more than 80% of children are anemic. This trial was performed in the field study area of the Kintampo Health Research Centre, located in the Kintampo district of Ghana, West Africa.
557 infants, 6-18 months of age with hemoglobin levels between 70-99 g/L, were randomized to receive either iron Sprinkles plus ascorbic acid (80 mg elemental iron) once per day or ferrous sulphate drops (40 mg elemental iron) 3 times per day for a total of 2 months. Hemoglobin and serum ferritin concentrations were assessed at baseline and after two months of treatment.
At the end of the treatment period, it was found that iron Sprinkles were as efficacious as ferrous sulphate drops, the gold standard, in treating IDA. Successful treatment of anemia (hemoglobin > 100 g/L) occurred in 58% of the Sprinkles group and in 56% of the drops group. In addition, Sprinkles was found to be well accepted and easier to use than the ferrous sulphate drops.
Study 2: Long-term follow-up of children successfully treated for anemia
Long-term follow-up of children successfully treated for anemia who are at heightened risk of recurrence has not been documented. It is not apparent whether these children would benefit from continued prophylactic iron supplementation, and which form of iron would be most suitable for long-term use.
We studied the same cohort of infants who were successfully treated for anemia (Hb=100 g/L) in study 1. Our objectives were:
(i) to evaluate the use of Sprinkles (with and without vitamin A) and ferrous sulfate drops compared to placebo Sprinkles
in preventing recurrence of anemia; and (ii) to determine the long-term hematologic outcome in this cohort of high risk infants 12 months post-supplementation.
A total of 324 infants were studied in this prospective randomized placebo-controlled design. Four groups were provided with iron Sprinkles (40 mg Fe); iron sprinkles with vitamin A (40 mg Fe + 2000 IU vitamin A); ferrous sulfate drops (12.5 mg Fe) or placebo sprinkles daily for six months. Following the supplementation period, non-anemic infants were reassessed at 12 months post-supplementation.
During the trial, 82.4% (267/324) maintained their non-anemic status; there was no significant difference between the groups, including placebo. Sprinkles were well accepted without complications. At 12 months post-supplementation, with no intervention, 77.1% (162/210) of children remained non-anemic.
We concluded that in the majority of infants previously treated for anemia, there was no need for further supplementation to maintain their non-anemic status. These results may have important implications for community intervention programs where initial high-dose treatment is necessary because of a high prevalence of anemia.
Study 3: Efficacy of Sprinkles as a multiple micronutrient supplement to treat anemic infants (Completed)
In study 1 we used Sprinkles to successfully treat anemia. This mode of micronutrient delivery is amenable to the delivery of other micronutrients. However, the relative efficacy of multiple micronutrient supplements for the treatment of anemia needs to be evaluated due to possible nutrient interactions. Relevant to iron supplementation is the interaction between iron and zinc which may reduce the absorption and bioavailabilty of both minerals.
A new cohort of 304 anemic infants were studied in this double-blind randomized clinical trial. We compared Sprinkles containing both iron and zinc (80 mg Fe and 10 mg Zn) with Sprinkles containing iron only (80 mg iron) in treating anemia for 2 months supplementation period.
Although both formulations were very successful in treating anemia, Sprinkles as a single micronutrient iron supplement resulted in a higher rate of recovery from anemia (74.8% vs. 62.9%). Sprinkles with added zinc failed to improve zinc status or growth over the short supplementation period.
Study 4: Bioavailability of iron and zinc from Sprinkles
(Contact: Melody Tondeur; In Progress)
The overall goal of this study is to develop a single Sprinkles intervention that can be effectively and safely used in anemic and non-anemic infants on a population basis. Thus, a single dose of iron for Sprinkles needs to be established to both treat and prevent IDA in all at risk infants.
A double-blinded randomized trial is being conducted in rural Ghana to determine the bioavailability of two different doses of ferrous fumarate from Sprinkles using a dual stable isotope method. Anemic (n=39) and non-anemic (n=40) infants aged 6-18 months are being studied. Infants are randomized to receive Sprinkles with either a 30 mg or a 45 mg dose of elemental iron as encapsulated ferrous fumarate labeled with 57-Fe, a stable, non-radioactive isotope of iron. To determine the incorporation of iron into newly formed erythrocytes, isotopic composition is being determined by ICP-MS.
Similarly, we are investigating the bioavailability of zinc (5 and 10 mg elemental zinc) from Sprinkles, which will also allow us to see how iron and zinc interact when combined as a supplement.
Literature values for the bioavailability of ferrous fumarate, when used to fortify infant cereal, are between 2-8%. We expect similar results from Sprinkles. Final analysis of the data should be completed by October 2002. This trial will allow us to understand iron and zinc absorption from Sprinkles and thus help us decide upon the best suitable dose and formulation.