Background The immediate and long-term effects of nutritional deficiencies are increased incidence and severity of acute conditions, impaired rates of growth, and retarded cognitive development. An efficacy intervention trial using novel supplementations Sprinkles (Suppleforte) was performed.
Methods Controlled cluster randomised trial. We compared the efficacy of Sprinkles (the Sprinkles arm received one-dose multiple micronutrients sachets) with the standard treatment (the Control arm received standard liquid iron and vitamins A+D) supplied free of charge to the families with children from 6 to 12M of age attending well-baby clinics. Infants were enrolled between July 2005 and September 2007 in 12 neighbourhood clinics (randomisation units, clusters).
Results The final study population comprised 621 eligible infants. There was a positive significant effect of intervention among children of Sprinkles groups on mean level of folic acid and zinc in both Bedouin and Jewish populations (p<0.05). Sprinkles use was associated with a reduced risk of iron deficiency (at least 2 of 6 iron deficiency anaemia indicators) at age 12M, compared with control intervention (OR=0.33, p=0.001) after controlling for the 6M iron status, iron consumption from food, breastfeeding duration and reported supplementations use. More Control Bedouin children were hospitalised for any/all infectious disease cause (27.2%), compared to the Sprinkles (14.6%, p=0.005). Significantly more adverse events (changes in stool colour, diarrhoea, and constipation) were reported in Controls than in Sprinkles in both ethnic populations.
Conclusions Sprinkles supplementation was associated with a marked reduction in risk of iron deficiency at age 12M and less adverse events and should be recommended formulations.
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