Micronutrient Sprinkles in a Daycare Center
Condition: Diarrhea; Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Diarrheal diseases are a major cause of morbidity and mortality globally in children less
      than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in
      developing countries are usually a consequence of micronutrient deficiencies including zinc.
      The primary aims of the proposed study are to evaluate the effect of the use of multiple
      micronutrient sprinkles including zinc on compliance of supplement use and the incidence of
      recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the
      Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da
      Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind
      placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group
      of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into
      2 groups of 60 children each. The intervention group will receive sprinkles containing zinc
      while the control group will receive micronutrient sprinkles without zinc. The primary
      outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both
      groups of infants will be monitored at monthly intervals for an initial duration of 180 days
      for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for
      the establishment of a cohort of children who will be monitored in a micronutrient
      supplementation trial using sprinkles.
    

Detailed description: 
      The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center,
      Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period
      of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of
      micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador,
      Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will
      receive sprinkles containing zinc while the control group will receive micronutrient
      sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc
      losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals
      for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness
      and growth. This study will allow for the establishment of a cohort of children who will be
      monitored in a micronutrient supplementation trial using sprinkles.
    

Intervention name(s): Micronutrient Sprinkles with zinc; Micronutrient sprinkles without zinc
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dose of 1 packet of sprinkles; I packet of micronutrient sprinkles without zinc
Other intervention name(s): Micronutrient sprinkles; Micronutrient sprinkles
Intervention MeSH terms: Zinc; Trace Elements; Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Diarrhea; Pneumonia; Upper respiratory infections; Acute gastroenteritis