Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a
      widespread serious public health problem, especially for infants in developing countries
      mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron
      in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by
      supplementation to targeted populations. Although iron drops have been used, they have been
      largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution
      and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as
      iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as
      a sustainable alternative to current iron supplementation approaches, an optimal model of use
      and distribution for Sprinkles® needs to be established. By comparing daily versus flexible
      use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged
      6-24 months, the primary objectives are to study the effect of the three administration
      models of Sprinkles® on changes in:

        1. hemoglobin concentration; and

        2. compliance or adherence to the intervention.

      ii. The secondary objective of this study is to determine the acceptability of each of the
      three intervention models.

      We hypothesize that adherence will be greater and hemoglobin concentration response will be
      higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a
      specific period of time compared to those given strict instructions for daily use.
    

Detailed description: 
      Study Design

      This study will follow a community-based cluster randomized clinical trial design involving
      three intervention groups. Total number of villages included in the study will be determined
      by the availability of the eligible children. In each village, all eligible children will be
      screened through house-to-house visits. After the screening, all the children will be
      randomized by village using a table with randomly assorted table into one of three groups:

        -  Daily use of 60 Sprinkles® sachets over 60 days.

        -  Flexible use of 60 Sprinkles® sachets over 90 days.

        -  Flexible use of 60 Sprinkles® sachets over 120 days.

      In all groups, assessments will be done at baseline, at the end of a group's intervention and
      at 6 months after intervention in each group for follow-up.

      The study will take place in Kaligong sub-district in Bangladesh. All villages in Kaligonj
      sub-district consist of plain agricultural land. Subsistence farming is the major source of
      livelihood. Rice is the commonly eaten staple mixed with lentil and vegetable curry and
      occasionally with pieces of fish and meat. Similar to the rest of the plain areas of the
      country, malnutrition among women and children is widespread, but malaria is extremely
      uncommon and the prevalence of hookworm is fairly low (less than 2%%).
    

Intervention name(s): Multiple micronutrient supplement (iron)
Intervention type(s): Drug
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: iron deficiency anemia; hematologic disease; infancy; pediatrics; Sprinkles®; iron; micronutrient