Nutrition News for Africa

Abstract - November 30, 2006

An article entitled “Multi-micronutrient Sprinkles including a low dose of iron provided as microencapsulated ferrous fumarate improves haematologic indices in anaemic children: a randomized clinical trial” was published by Christofides et al. in the journal compilation Maternal and Child Nutrition 2, pp.169-180, 2006 Blackwell Publishing Ltd.

Iron deficiency anaemia among infants and young children is a health priority of the WHO and UNICEF. “Sprinkles” are a “complementary food supplement” containing micronutrients in powder form that are packaged in single dose sachets and that are sprinkled onto food after cooking to increase its micronutrient density. There is no available information on the efficacy of low doses of Sprinkles, which are preferred in community settings, when added to complementary foods. The aim of the present study was to determine the lowest possible effective dose and optimal method of treatment for improving hemoglobin (Hb) concentration in anaemic children using a clustered randomized clinical trial.

The study took place from April to September 2003 in the Kintampo district of Ghana. This is a malaria-endemic area where the principle complementary food is an unfermented maize-based porridge. Eligibility criteria included, among others, age between 6 and 18 months and an Hb concentration in the interval of 77-99 g/L. Housing compounds were randomly assigned to one of five intervention groups: one using iron drops (12.5mg) as ferrous sulfate (FS), and four using Sprinkles. Of the four Sprinkles groups, three provided iron as microencapsulated ferrous fumarate (FF) at doses of 12.5mg, 20mg and 30mg, and one provided iron as micronized pherric pyrophosphate (MFP) at a dose of 20mg. The Sprinkles sachets also included other micronutrients. Instructions were given to add the contents of the sachet to the children’s meal at serving, once daily for an 8-week period at any mealtime. The FS group instructions were to give 1mL of liquid iron daily between meals during the same 8-week period. The primary outcome was Hb concentration at 8 weeks from baseline.

Baseline assessments took place at a health clinic and included a questionnaire as well as anthropometric and biochemical measurements. Malaria positivity was also determined at that time. Field workers visited participants in their homes weekly after the baseline visit for a total of seven follow-up visits. At each visit a questionnaire on adherence, ease of use and side effects over the preceding week was completed, and verbal education support was provided. At 3 weeks from baseline, Hb concentration was reassessed and at 8 weeks, anthropometric and biochemical measurements were repeated.

A total of 133 children entered the study and a total of 118 (89%) completed the study with complete data including biochemical indices available for 86% of children.

At baseline, mean Hb varied from 87 to 91 g/L; at week 3, it varied from 100 to 107g/L and at 8 weeks it varied from 102 to 110 g/L. The change in Hb concentrations from baseline to week 8 was significant in all groups, but no significant difference was observed between groups and the differences between any two groups were not significant. Sprinkles adherence was 85% in FF12.5, 84% in FF20 and FF30, and 83% in MFP and adherence in the FS group was significantly lower at 69%. Reported ease of use was higher in the Sprinkles group and although side effects were similar among the Sprinkles groups, the reported staining of the teeth was higher in the FS group.

The overall results suggest that multi-micronutrient Sprinkles may have better acceptability and compliance in a community setting. The authors found that there was a significant association between baseline measures of low Hb concentrations and malaria positivity and recommended that adequately powered studies be conducted. The authors comment that their results are not generalizable to iron fortification programs that are meant for entire populations and for indefinite periods of time but that they are generalizable to settings where the prevalence of anemia is high. The authors conclude that their results seem to suggest that iron is well absorbed in iron-deficient children even when the iron is mixed with foods and when the dose of iron is as low as 12.5mg, and recommend that further research be undertaken to determine the effectiveness of this dose in program settings.