Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Condition: Zinc Deficiency; Diarrhea; Malaria
MeSH terms: Malaria; Diarrhea
Study type: Interventional

Summary: 
      Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency
      or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to
      determine how best to integrate programs designed either to prevent zinc deficiency or to
      treat diarrhea.

      The overall objective of this project is to determine the most effective approach to prevent
      zinc deficiency and treat diarrhea, such that a single approach could provide the maximal
      beneficial impact on the health and nutritional status of young children and greatest
      simplicity of implementation.
    

Detailed description: 
      This is a single-center cluster- and household-randomized, partially masked, community-based
      efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one
      region, with 34 clusters randomly assigned to 3 types of intervention communities.

      Communities will be randomly assigned to 1) early intervention communities, 2) later
      intervention communities, 3) non-intervention communities. Within each intervention cluster,
      children will be randomly assigned to the intervention group at the household level. Children
      aged 6-27 months at enrollment will be eligible. The study duration is 12 months.

      The investigators will assess the relative impact of daily preventive zinc supplementation (7
      mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days
      every three months for one year), and zinc treatment during episodes of diarrhea (20 mg
      zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that
      will be assessed include the incidence and duration of all episodes of diarrhea, the
      incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc,
      iron and vitamin A status.
    

Intervention name(s): Daily preventive Zn; placebo treatment; Therapeutic Zn; daily placebo; Intermittent Zn; placebo treatment; Surveillance control group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 7 mg zinc / day and placebo supplement during diarrhea episodes; 20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement; 10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes; Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
Other intervention name(s): Nutriset preventive zinc and therapeutic placebo supplement; Nutriset ZinCfant; Nutriset zinc supplement
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: zinc supplementation; diarrhea management; zinc deficiency; malaria