Efficacy of multiple micronutrient supplementations on child health: study design and baseline characteristics.
The rates of anemia in children in southern Israel are high despite the current prevention strategy. A daily dose of "Sprinkles" (SuppleForte, Heinz, Canada), a micronutrient home supplementation, was proven effective for the treatment of anemia worldwide. To assess the efficacy of Sprinkles, a novel supplementation formulation, in the primary prevention of anemia in infants who have free access to health care services. A two-arm open-labeled cluster randomized controlled clinical trial was performed in 6 month old Bedouin and Jewish infants. The Sprinkles arm received sachets with iron, vitamins A and C, folic acid and zinc, and the control arm received standard treatment (liquid iron and vitamins A and D). The infants were from families attending Mother and Child Health clinics during 2005-2007. Intervention and follow-up were conducted for babies aged 6-12 months. Health outcomes (hematologic and nutritional indicators, growth parameters, morbidity rates) were evaluated at 12 and 18 months. The final study population numbered 621 infants (328 Bedouin and 293 Jewish); of the parents approached 88.5% agreed to participate. Hemoglobin > 11 g/dl was found in 55% of Bedouin and 40% of Jewish infants (P < 0.01). Bedouin infants had significantly lower serum concentration of iron, folic acid and zinc. All background, hematologic and micronutrient indicators were similar in the two study arms except for a slightly but not clinically significant difference in hemoglobin and hematocrit levels in Bedouins. Our findings indicate the need to improve the micronutrient status of infants living in the Negev. A cluster randomized trial in MCH clinics is a feasible option.